SYNCHROMED II
Report
- Report Number
- 3004209178-2014-00817
- Event Type
- Injury
- Date Received
- January 17, 2014
- Report Date
- January 2, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, LOT# N175631007, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-1, LOT# N182450, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. (B)(4).
UPDATED TO SERIOUS INJURY.
(B)(4).
IT WAS REPORTED THAT A CT MYELOGRAM REVEALED THAT THE CATHETER WAS FRACTURED, BROKE OFF AND WAS NOT IN THE INTRATHECAL SPACE. THE DISTAL PIECE OF THE CATHETER COULD NOT BE FOUND. THE CATHETER IN THE SPINAL SEGMENT THAT WAS REMAINING NOTED 13 ON IT FOR A MARKER. REPORTEDLY, 10 CENTIMETERS (CM) WAS CURRENTLY MISSING. A CATHETER REVISION WAS PERFORMED AND AN 8598A, 24.9 CM WAS ADDED TO THE EXISTING 8709. THE HEALTH CARE PROVIDER (HCP) WAS GOING TO DILUTE THE DRUG DILAUDID 14 MILLIGRAMS (MG) PER MILLILITER (ML) TO 400 MICROGRAM (MCG) /ML. THE PUMP WAS TO BE PROGRAMMED TO MINIMUM RATE AND THE OLD DRUG WOULD CLEAR THE SYSTEM IN 80.8 DAYS. NO PRIME WAS PROGRAMMED. THIS DEVICE SYSTEM DELIVERED DILAUDID. ADDITIONAL INFORMATION WAS REQUESTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS HAVING LOW BACK PAIN. THE CATHETER TIP WAS NOT FOUND. NO TROUBLESHOOTING OR OTHER ACTIONS WERE PERFORMED AND THE PATIENT WAS CURRENTLY REPORTED AS DOING BETTER. 2015-04-28 LEGAL X2, E2, CRTS 3234626 (CON/ATTORNEY): PER THE ATTORNEY, ON (B)(6) 2014, THE PATIENT WAS TAKEN IN FOR A PUMP REVISION DUE TO CONTINUAL SEVERE LOW BACK PAIN DESPITE DOSE INCREASES. DURING THE PROCEDURE, UPON RELEASING THE ANCHOR IT WAS NOTED THAT THE TIP OF THE CATHETER WAS MISSING WITH THE EDGE OF THE OLD CATHETER BEING RAGGED AND CUT; THERE WAS NO DISTAL PIECE OF THE CATHETER ¿TO SALVAGE¿. THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2014 WITH PAIN AND SWELLING IN THE AREA OF THE PAIN PUMP. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2014 THRU (B)(6) 2014. DURING THE HOSPITAL ADMISSION, THE PATIENT¿S DEVICES WERE REMOVED. IN ADDITION, THE PATIENT UNDERWENT SURGERY TO REMOVE THE CATHETER TIP THAT WAS LODGED IN HER LUMBAR SPINE. THE PATIENT WAS DIAGNOSED WITH A PUMP POCKET INFECTION AND ¿STAPHYLOCOCCUS AUREUS MENINGITIS¿. AS A RESULT OF THE EVENT, THE PATIENT SUFFERED ¿SEVERE PAIN, INFECTION, AND OTHER INJURIES¿; SUFFERED ¿SEVERE AND PERMANENT INJURIES¿; AND SUFFERED ¿SEVERE PERSONAL INJURIES, PAIN AND SUFFERING, MENTAL ANGUISH AND EMOTIONAL DISTRESS¿. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER REGARDING A PATIENT RECEIVING INTRATHECAL DILAUDID 14MG/ML AT 2.8MG/DAY AND CLONIDINE AT AN UNKNOWN DOSE AND CONCENTRATION. THE LOT NUMBERS WERE UNKNOWN. THE INDICATIONS FOR USE WERE LUMBAR RADICULOPATHY AND NON-MALIGNANT PAIN. THE PATIENT WAS AN (B)(6) WOMAN WHO WAS DIAGNOSED WITH LUMBAR POST-LAMINECTOMY SYNDROME AND INTRACTABLE CHRONIC LOW BACK PAIN FOR MANY YEARS. THE PATIENT¿S SPECIFIC CASE OF POST-LAMINECTOMY SYNDROME AND INTRACTABLE CHRONIC LOW BACK PAIN HAD CAUSED HER SEVERE AND CHRONIC PAIN WITH AGGRAVATING FACTORS OF BENDING, LIFTING, STANDING, OR SITTING FOR LONG PERIODS OF TIME. IN ORDER TO TREAT HER BACK PAIN, THE HEALTH CARE PROVIDER (HCP) TRIED SEVERAL METHODS, SUCH AS IMPLANTATION OF A SPINAL CORD STIMULATOR, LUMBAR STEROID INJECTIONS, LUMBAR FACET BLOCK, PEDICLE SCREWS, AND BACK FUSION. NONE OF THESE TREATMENTS PROVIDED LASTING RELIEF FROM HER SEVERE CHRONIC PAIN. IN AN ATTEMPT TO MANAGE HER SYMPTOMS, ON 2009-01-15, THE PATIENT UNDERWENT AN INTRATHECAL PUMP TRIAL, RESULTING IN AN 80% DECREASE IN HER PAIN DURING THE TRIAL. MEDICAL RECORDS NOTED THAT HER FAMILY NOTICED A DIFFERENCE, NAMELY THAT THE PATIENT ¿WAS HAPPIER, MAKING JOKES, AND MOVING MORE EFFORTLESSLY COMPARED TO BEFORE AND AFTER THE TRIAL.¿ BECAUSE CLINICAL IMPROVEMENT WAS DEMONSTRATED DURING THE TRIAL, ON (B)(6) 2009, A SYSTEM WAS IMPLANTED IN THE PATIENT. THE SYSTEM WAS IMPLANTED TO ADMINISTER A CONTINUOUS INTRATHECAL DOSE OF DIALUDID AND CLONIDINE TO CONTROL THE PATIENT¿S PAIN. PRIOR TO IMPLANTATION, THE PATIENT WAS ABLE TO WALK, BUY GROCERIES, AND PERFORM HOUSEHOLD CHORES DESPITE HER MEDICAL CONDITION. THE NEW IMPLANTED SYSTEM NEVER DELIVERED THE RELIEF FROM PAIN THAT THE PATIENT EXPERIENCED DURING HER PRE-IMPLANTATION PUMP TRIAL. SHORTLY AFTER THE SYSTEM WAS IMPLANTED, THE PATIENT BEGAN TO SUFFER COMPLICATIONS. HER BACK PAIN WAS NOT ALLEVIATED, AS PROMISED IN THE BROCHURES ADVERTISING THE PUMP SYSTEM, OR AS PROMISED BY THE MANUFACTURING REPRESENTATIVES, WHO AT TIMES WOULD APPEAR IN THE HCP¿S OFFICE ¿SELLING THE IDEA¿ OF HER USING AN IMPLANTABLE PUMP SYSTEM. ON (B)(6) 2011, BELIEVING THE MEDICATION WAS NOT BEING DELIVERED TO THE INTRATHECAL SPACE, THE HCP PERFORMED A REVISION SURGERY TO REPLACE THE MALFUNCTIONING SYSTEM. DESPITE THE REVISION SURGERY AND RE-IMPLANTATION OF THE SYSTEM, THE PATIENT¿S SEVERE PAIN CONTINUED. ANOTHER SURGERY TO REPAIR THE PUMP WAS SCHEDULED DUE TO ¿CONTINUAL SEVERE LOW BACK PAIN WITH PUMP IMPLANT ON (B)(6) 2011 AND WITH PROGRESSIVE INCREASE OF THE PUMP MEDICATION RATE¿¿ ON (B)(6) 2014, THE HCP PERFORMED ANOTHER REVISION SURGERY AND EXPLANTED THE MALFUNCTIONING PUMP. THE PUMP WAS SUBJECT OF THE FDA¿S AUGUST 2011 UPDATED CLASS I DEVICE RECALL "DUE TO THE POTENT IAL FOR REDUCED BATTERY PERFORMANCE THAT CAN LEAD TO A SUDDEN LOSS OF THERAPY". THE DATE OF THE RECALL WAS JULY 2009. AT NO TIME DURING THE YEARS THE PATIENT SUFFERED FROM LACK OF THERAPY DUE TO HER MALFUNCTIONING PUMP DID THE DEVICE MANUFACTURER INFORM HER THAT HER DEVICE WAS RECALLED DUE TO REDUCED BATTERY PERFORMANCE. IN MAY OF 2013, THE FDA REQUIRED THE DEVICE MANUFACTURER TO ISSUE AN "URGENT: MEDICAL DEVICE REMOVAL' LETTER TO HEALTH CARE PROVIDER CUSTOMERS WITH SUTURELESS CONNECTOR INTRATHECAL CATHETER PRODUCTS, INCLUDING CATHETER MODEL NUMBER 8709W AND REVISION KIT MODEL NUMBER 8578. IN THE LETTER, THE DEVICE MANUFACTURER NOTED A REDESIGN INTENDED TO REDUCE THE "POTENTIAL FOR OCCLUSION AT THE CATHETER TO PUMP INTERFACE." ACCORDING TO THE LETTER, ALL UNUSED MODELS 8709SC, 8731SC, 8596SC, 8578 WITH A "USE BY" DATE PRIOR TO 2014-08-25 WERE TO BE REMOVED FROM THE MARKET. DESPITE THE FACT THAT THE "URGENT" WARNING COVERED THE PATIENT¿S FAILED CATHETER, SHE NEVER RECEIVED THE LETTER. ON (B)(6) 2014, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM DUE TO AN INFECTED PUMP AND CATHETER SYSTEM. SHE WAS HOSPITALIZED FOR OVER A WEEK, AND DURING THAT TIME, SHE AGAIN UNDERWENT SURGERY FOR "REMOVAL OF INTRATHECAL CATHETER" AND INTRATHECAL PUMP. THE PATIENT ALSO REQUIRED REMOVAL OF A CATHETER TIP THAT WAS LODGED IN HER LUMBAR SPINE LEFT, (AS INSTRUCTED BY THE DEVICE MANUFACTURER) FROM A PREVIOUS IMPLANTATION PROCEDURE. STAPHYLOCOCCUS AUREUS WAS ISOLATED FROM HER SPINAL FLUID, THE CATHETER TIP AND ABSCESS DRAINAGE. THE DIAGNOSIS FROM THIS ADMISSION INCLUDED: "PAIN PUMP POCKET INFECTION" AND "STAPHYLOCOCCUS AUREUS MENINGITIS." THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS FOR SIX (6) WEEKS. UNFORTUNATELY, THE IV LINE DELIVERING THE ANTIBIOTICS BECAME INFECTED AND THE PATIENT WAS READMITTED TO TREAT THIS SECOND INFECTION AND RESULTING CELLULITIS FROM (B)(6) 2014 THROUGH (B)(6) 2014. THE PATIENT UTILIZED A ¿DEFECTIVE MEDICAL DEVICE¿ AND THEREBY SUFFERED SERIOUS AND PERMANENT PERSONAL INJURIES AS A DIRECT AND PROXIMATE RESULT OF THE DEVICE'S DEFECTS . DUE TO KNOWN FAILURES OF THE SUBJECT CATHETER, THE FDA APPROVED THE DEVICE MANUFACTURER¿S CHANGES TO THE PATIENT¿S 8709SC CATHETER BEFORE HER SURGERY IN 2009. HOWEVER, THE DEVICE MANUFACTURER CONTINUED TO MARKET, DISTRIBUTE, AND SELL MALFUNCTIONING CATHETERS AND MALFUNCTIONING CATHETER CONNECTIONS, INCLUDING THE PATIENT¿S, EVEN WHEN FACED WITH NUMEROUS COMPLAINTS RELATED TO CATHETER OCCLUSION AND SEPARATION OF THE SUBJECT CATHETER . HAD THE PATIENT KNOWN ABOUT THE MALFUNCTIONING CATHETERS, SHE WOULD HAVE NOT PURCHASED THE SYSTEM, NOR HAD IT IMPLANTED IN HER BODY. THE PATIENT¿S CATASTROPHIC INJURY WAS EASILY PREVENTABLE BY THE DEVICE MANUFACTURER, SIMPLY BY AVOIDING THE SALE AND DISTRIBUTION OF A DANGEROUS CATHETER. THE DEVICE MANUFACTURER KNEW THE RISK OF ITS DANGEROUS CATHETERS, YET PUT THE PATIENT IN HARM'S WAY BY INTRODUCING THE SUBJECT CATHETER INTO THE STREAM OF COMMERCE. THE DEVICE MANUFACTURER¿S FAILURE TO COMPLY WITH FEDERAL REGULATIONS AND FEDERAL STATUTES IN THE MANUFACTURE OF THE SYSTEM, AND IN THE DELAY OF IMPLEMENTING CHANGES THAT COULD HAVE PREVENTED PATIENT¿S INJURY, WAS A SUBSTANTIAL FACTOR IN CAUSING PLAINTIFF'S HARM. THE PATIENT¿S INJURIES PROXIMATELY RESULTED FROM THE NEGLIGENT AND/OR OTHER WRONGFUL ACTS AND/OR OMISSIONS AND FRAUDULENT MISREPRESENTATIONS OF THE DEVICE MANUFACTURER, TO THE PATIENT AND OTHERS. THE PATIENT HAD SUFFERED AND WOULD CONTINUE TO SUFFER DAMAGES, INCLUDING LOST WAGES AND BENEFITS, DIMINISHED WAGES AND FUTURE EARNINGS, MENTAL ANXIETY AND ANGUISH, LOSS OF SELF-ESTEEM, AND MEDICAL BILLS ALL TO THE DAMAGE OF PATIENT. IT WAS NOTED THAT ON 2015-04-27, THE UNITED STATES DISTRICT COURT JUDGE SIGNED A CONSENT DECREE OF PERMANENT INJUNCTION AGAINST THE DEVICE MANUFACTURER, PREVENTING THE MANUFACTURE AND DISTRIBUTION OF THE SYSTEM IN VIOLATION OF THE TERMS OF THE CONSENT DECREE. THE CONSUMER ALLEGED THAT TO THIS DAY, THE DEVICE MANUFACTURER CONTINUES TO SELL THEIR SYSTEM, IN DIRECT VIOLATION OF THE CONSENT DECREE AND DESPITE ITS FAILURES TO RECTIFY OR OTHERWISE ELIMINATE ITS MULTIPLE VIOLATIONS OF FEDERAL LAW IN THE MANUFACTURE OF ITS DEVICE. THE DEVICE MANUFACTURER FAILED TO MANUFACTURE THE SYSTEM IN A MANNER SUCH THAT IT WOULD SAFELY AND EFFECTIVELY PERFORM AS INTENDED AND SUCH THAT THE CATHETER AND/OR CONNECTOR COMPONENTS OF THE SYSTEM WOULD REMAIN INTACT AND WOULD FUNCTION PROPERLY AND SAFELY. THE DEVICE MANUFACTURER WAS IN VIOLATION OF THE CGMP REQUIREMENTS AND OTHER FEDERAL LAW AND THE DEVICE MANUFACTURER SPECIFICALLY HAD BEEN CITED BY THE FDA ON MULTIPLE OCCASIONS FOR MANUFACTURING "ADULTERATED" AND "MISBRANDED" SYSTEMS AS A RESULT OF ITS NON-COMPLIANCE AND NONCONFORMANCE WITH CGMPS. THE DEVICE MANUFACTURER KNEW, AT ALL TIMES BEFORE THE PATIENT WAS IMPLANTED WITH A SYSTEM, THAT THE PATIENT¿S SYSTEM DEVICES WERE "ADULTERATED" AND "MISBRANDED" DESPITE REPRESENTING TO THE PATIENT AND THE PATIENT'S MEDICAL PROVIDERS THAT THE DEVICES WERE "SAFE AND EFFECTIVE" AND "APPROVED BY THE FDA." AT THE TIME THE PATIENT¿S SYSTEM WAS MANUFACTURED AND/OR PACKAGED AND/OR LABELED AND/OR DISTRIBUTED, THE DEVICE MANUFACTURER HAD FAILED TO COMPLY WITH CGMP REQUIREMENTS AND OTHER FEDERAL LAW, AND THE SYSTEM DID NOT COMPLY WITH THE FDCA AND APPLICABLE FEDERAL REGULATIONS AND STATUTES AND WERE THEREFORE NOT IN CONFORMANCE WITH FEDERAL LAW GOVERNING THE SAFE MANUFACTURE AND PERFORMANCE OF THE SYSTEM, AND THE DEVICE MANUFACTURER THEREBY VIOLATED PARALLEL STATE LAW BY FAILING TO USE REASONABLE CARE IN MANUFACTURING THE SYSTEM SO AS TO PROTECT USERS OF THEIR PRODUCT SUCH AS THE PATIENT. THROUGH ITS FAILURE TO CONFORM TO CGMPS (AND/OR OTHER APPLICABLE REGULATIONS), THE DEVICE MANUFACTURER WAS UNABLE TO VERIFY, IN ACCORDANCE WITH FDA REGULATIONS, THAT THE PATIENT¿S SYSTEM WAS SAFE AND EFFECTIVE, FULLY CONFORMED TO SPECIFICATIONS, AND WAS FREE OF MANUFACTURING DEFECTS THAT COULD LEAD TO MALFUNCTIONS HAVING THE POTENTIAL TO CAUSE OR CONTRIBUTE TO SERIOUS BODILY INJURY AND/OR DEATH. THE SYSTEM AT ISSUE MALFUNCTIONED AS A DIRECT AND PROXIMATE RESULT OF MANUFACTURING DEFECTS ALLEGED; FAILING TO DELIVER, WITHOUT WARNING OF ANY MALFUNCTION, THE PROGRAMMED DOSE OF MEDICINE AND THEREFORE DID NOT PERFORM IN ACCORDANCE WITH OR CONFORM TO THE SPECIFICATIONS OF REGULATIONS IN THE MANUFACTURING PROCESS OF THE SYSTEM, WHICH FORMED THE BASIS OF THE FDA'S APPROVAL TO MARKET THE DEVICE. THE CATHETERS AT ISSUE WERE OCCLUDED, FRACTURED, OBSTRUCTED, AND/OR MALFUNCTIONING, WHICH CAUSED THE PATIENT TO SUFFER SEVERE INJURIES AND WHICH REQUIRED MULTIPLE SURGERIES AND MEDICAL PROCEDURES TO CORRECT THESE DEFECTS. THESE PRODUCT FAILURES WERE THE RESULT OF VIOLATIONS OF FEDERAL LAW THAT OCCURRED DURING THE MANUFACTURING PROCESS OF THE DEVICES AND WHICH FORMED THE BASIS OF THE FDA'S APPROVAL TO MARKET THE DEVICE. THE DEVICE MANUFACTURER PLACED INTO THE STREAM OF COMMERCE THE SYSTEM AT ISSUE, WHICH REACHED THE PATIENT WITHOUT SUBSTANTIAL CHANGE IN CONDITION AND FAILED TO PERFORM IN ACCORDANCE WITH OR CONFORM TO THE SPECIFICATIONS APPROVED BY THE FDA AND/OR FAILED TO FUNCTION AS INTENDED AND/OR MALFUNCTIONED AND WERE THEREFORE NOT SAFE AND EFFECTIVE, WERE UNFIT FOR THEIR INTENDED AND FORESEEABLE USES, AND WERE IN A DEFECTIVE AND DANGEROUS CONDITION AT THE TIME THEY WERE USED BY THE PATIENT. THE DEVICE MANUFACTURER CAUSED OR OTHERWISE ALLOWED, ENABLED OR FACILITATED THE PLACEMENT OF DANGEROUS PRODUCTS IN A DEFECTIVE CONDITION INTO THE STREAM OF COMMERCE AND FAILED TO WARN THE PATIENT, PATIENT¿S MEDICAL PROVIDERS, AND THE FDA OF ITS DEFECTIVE NATURE. THE SYSTEM AND/OR ITS RELATED EQUIPMENT WAS IN A DANGEROUS AND DEFECTIVE CONDITION AT THE TIME IT REACHED THE PATIENT, INCLUDING BUT NOT LIMITED TO DEFECTS IN THE SUBJECT CATHETER, AND AS A DIRECT RESULT OF THE DEFECTS (AND THE DEVICE MANUFACTURER¿S FAILURE TO WARN THE PATIENT, PATIENT¿S HCP, OR THE FDA), THE PATIENT SUFFERED CRIPPLING INJURIES WHICH LEFT THE PATIENT WITH PERMANENT AND SIGNIFICANT DISABILITIES. IT WAS NOTED THAT IN THE STATE OF CALIFORNIA, A MEDICAL DEVICE MANUFACTURER HAS A DUTY TO USE REASONABLE CARE TO PROVIDE POST-SALE WARNINGS OF PRODUCT DANGERS TO PERSONS, SUCH AS THE PATIENT, WHO MAY BE EXPOSED TO HARM WHEN THE PRODUCT IS USED AS INTENDED, OR IS USED IN A WAY THAT THE MANUFACTURER COULD HAVE REASONABLY ANTICIPATED. THE DEVICE MANUFACTURER KNEW AT ALL TIMES BEFORE THE PATIENT WAS IMPLANTED WITH THE SYSTEM, THAT THE CATHETERS THAT PATIENT WOULD RECEIVE WERE DEFECTIVE AND BECAME OCCLUDED, FRACTURED, AND/OR OBSTRUCTED, AND/OR MALFUNCTIONED AT A HIGH RATE, BUT FAILED TO INFORM OR OTHERWISE WARN THE FDA, MEDICAL PROVIDERS, AND CONSUMERS SUCH AS PATIENT OF THE HIGH FAILURE RATES. HAD THE PATIENT, PATIENT'S MEDICAL PROVIDERS, AND/OR THE FDA BEEN PROPERLY WARNED OF THE HIGH FAILURE RATES OF THE CATHETERS AT ISSUE, THE PATIENT COULD HAVE AVOIDED THE INJURIES THEY SUFFERED. THE DEVICE MANUFACTURER FAILED TO PROVIDE THE PATIENT WITH ANY WARNING THAT THE DEVICES WERE NOT MANUFACTURED IN CONFORMANCE WITH CGMPS AND OTHER FEDERAL REGULATIONS. THE PATIENT AND PATIENT¿S MEDICAL PROVIDERS RELIED UPON THE DEVICE MANUFACTURER¿S EXPRESS WARRANTIES THAT SYSTEM CONFORMED TO FDA REGULATIONS AND SPECIFICATIONS, AND WAS SAFE, EFFECTIVE, FIT AND PROPER FOR ITS INTENDED USES AND FORESEEABLE USES WHEN IN FACT IT WAS MANUFACTURED IN VIOLATION OF FEDERAL REGULATIONS AND SPECIFICATIONS AND WAS UNSAFE AND UNFIT FOR SUCH USES . THE WARRANTY AND REPRESENTATIONS WERE UNTRUE IN THAT: THE FDA HAD DETERMINED THAT THE SYSTEM IMPLANTED IN THE PATIENT WAS MANUFACTURED IN VIOLATION OF FEDERAL REGULATIONS AND SPECIFICATIONS, INCLUDING CGMPS. THE FDA VIOLATIONS OF CGMPS COMMITTED BY THE DEVICE MANUFACTURER MEANT THAT THE DEVICE MANUFACTURER WAS UNABLE TO CONFIRM THAT THE SYSTEM IMPLANTED IN THE PATIENT WAS SAFE AND EFFECTIVE, FULLY CONFORMED TO SPECIFICATIONS, AND WAS FREE OF DEFECTS THAT COULD LEAD TO MALFUNCTIONS HAVING THE POTENTIAL TO CAUSE OR CONTRIBUTE TO SERIOUS BODILY INJURY; AND THE FDA HAD DETERMINED THAT THE SYSTEM IMPLANTED IN THE PATIENT WAS MANUFACTURED AT A TIME WHEN THE DEVICES WERE LABELED "ADULTERATED" AND "MISBRANDED". THE PATIENT PURCHASED AND USED THE SYSTEM BASED UPON THE EXPRESS WARRANTIES OF THE DEVICE MANUFACTURER, AND AS A RESULT THEREOF, THE PATIENT SUFFERED SEVERE AND PERMANENT INJURIES. PRIOR TO THE TIME THAT THE SYSTEM WAS IMPLANTED IN THE PATIENT; THE DEVICE MANUFACTURER IMPLIEDLY WARRANTED TO PATIENT AND/OR THE PATIENT¿S MEDICAL PROVIDERS THAT THE SYSTEM WAS SAFE AND FIT FOR THE PURPOSES FOR WHICH IT WAS INTENDED AND PROVIDED AND THAT THE SYSTEM WAS OF MERCHANTABLE QUALITY, WAS MANUFACTURED, AND/OR PACKAGED, AND/OR LABELED IN ACCORDANCE WITH FDA REGULATIONS, COMPLIED WITH APPLICABLE FDA APPROVED SPECIFICATIONS, AND WAS SAFE EFFECTIVE, AND FIT FOR THE USE FOR WHICH IT WAS INTENDED, OR FOR OTHER KNOWN OR FORESEEABLE USES. THE PATIENT WAS UNSKILLED IN THE RESEARCH, DESIGN, AND MANUFACTURE OF SYSTEM AND REASONABLY RELIED ENTIRELY ON THE SKILL, JUDGMENT, AND IMPLIED WARRANTIES OF THE DEVICE MANUFACTURER, IN BEING PRESCRIBED, PURCHASING, CONSUMING, AND OTHERWISE UTILIZING THE SYSTEM. AT THE TIME AND PLACE THAT THE PATIENT PURCHASED AND USED THE SYSTEM, THE PATIENT RELIED UPON THE DEVICE MANUFACTURER¿S IMPLIED WARRANTIES, NOT KNOWING THAT THE DEVICE MANUFACTURER KNEW, THAT IN FACT THE SYSTEM WAS UNFIT AND UNSAFE FOR THE PURPOSES FOR WHICH IT WAS PROVIDED, AND HAD BEEN FOUND BY THE FDA TO BE "ADULTERATED" AND "MISBRANDED", IN THAT IT WAS NOT MANUFACTURED, AND/OR PACKAGED, AND/OR LABELED IN ACCORDANCE WITH FDA REGULATIONS, DID NOT PERFORM TO OR PERFORM IN ACCORDANCE WITH APPROVED SPECIFICATIONS AND WAS THEREFORE NOT SAFE NOR EFFECTIVE FOR THE INTENDED, KNOWN, OR FORESEEABLE USES, NOR OF MERCHANTABLE QUALITY, AS WARRANTED BY THE DEVICE MANUFACTURER. THE SYSTEM IMPLANTED IN PLAINTIFF, HAD THE POTENTIAL TO MALFUNCTION AND CAUSE SERIOUS AND PERMANENT INJURIES, INCLUDING DEATH, WHEN PUT TO ITS INTENDED, KNOWN, OR FORESEEABLE USES. AS A RESULT OF THE BREACH OF THE IMPLIED WARRANTIES BY THE DEVICE MANUFACTURER, THE PATIENT, AFTER BEING IMPLANTED WITH, AND/OR AFTER PURCHASING, AND/OR OTHERWISE UTILIZING THE DEVICE MANUFACTURER¿S NON-CONFORMING, DEFECTIVE PRODUCTS, SUFFERED INJURIES AND SUSTAINED DAMAGES. THE DEVICE MANUFACTURER NEGLIGENTLY OR INTENTIONALLY MADE REPRESENTATIONS OF MATERIAL FACTS TO THE PATIENT, THE CONSUMING PUBLIC, THE MEDICAL COMMUNITY, AND THE FDA ABOUT THE SYSTEM WHICH WERE IN FACT, FALSE, INCLUDING BUT NOT LIMITED TO THE FOLLOWING: A. "A SAFER WAY TO RECEIVE PAIN MEDICATION"; B. "HELP YOU REJOIN LIFE SO YOU CAN GET BACK TO THE ACTIVITIES AND PEOPLE THAT MAKE YOU HAPPIEST"; C. "ALLOWS YOU TO 'TAME YOUR PAIN' "; D. "REDUCE YOUR NEED FOR ORAL PAIN MEDICATIONS"; E. "PROVIDE PEACE OF MIND KNOWING THAT YOU'VE SELECTED A DRUG DELIVERY SYSTEM THAT WAS MANUFACTURED BY THE DEVICE MANUFACTURER. . ."; G. "INCREASE YOUR CONFIDENCE WHEN YOU CONSIDER THAT MORE THAN 150,000 PEOPLE WORLDWIDE HAVE USED THE DEVICE MANUFACTURER DRUG DELIVERY THERAPY TO MANAGE THEIR CHRONIC PAIN"; H. "DRUG DELIVERY THERAPY FROM THE DEVICE MANUFACTURER IS A PROVEN SAFE AND EFFECTIVE THERAPY"; I. "THE DEVICE MANUFACTURER¿S 'DRUG DELIVERY THERAPY HAS BEEN TESTED, IS SHIPPED STERILE, AND IS FDA APPROVED"; AND J. "MORE DOCTORS TRUST THE DEVICE MANUFACTURER THAN ANY OTHER COMPANY OFFERING DRUG DELIVERY THERAPY." AT ALL TIMES THAT THE DEVICE MANUFACTURER MADE THESE REPRESENTATIONS, THE DEVICE MANUFACTURER HAD NO REASONABLE GROUNDS FOR BELIEVING THE REPRESENTATIONS WERE TRUE AND LATER, KNEW THEY WERE FALSE. THE DEVICE MANUFACTURER MADE THE REPRESENTATIONS WITH THE INTENT TO DEFRAUD AND INDUCE THE PATIENT TO PURCHASE AND USE THE SYSTEM. AT THE TIME THE PATIENT PURCHASED THE SYSTEM, THE PATIENT DID NOT KNOW THE REPRESENTATIONS WERE FALSE AND BELIEVED THEY WERE TRUE. THE PATIENT ACTED IN JUSTIFIABLE RELIANCE UPON THE REPRESENTATIONS. THE DEVICE MANUFACTURER CONCEALED OR SUPPRESSED MATERIAL FACTS REGARDING THE DANGERS POSED BY THE SYSTEM AND ITS LACK OF EFFICACY. THE DEVICE MANUFACTURER HAD A DUTY TO DISCLOSE THE MATERIAL FACTS TO THE MEDICAL COMMUNITY SO THAT DOCTORS COULD INFORM THE PATIENT AND OTHER PATIENTS. THE DEVICE MANUFACTURER ALSO TOLD DOCTORS AND THE PATIENT OTHER FACTS TO MISLEAD THE PATIENT AND PREVENT THE PATIENT FROM DISCOVERING THE CONCEALED OR SUPPRESSED FACTS. THE DEVICE MANUFACTURER CONCEALED OR SUPPRESSED THESE FACTS WITH THE INTENT TO DEFRAUD AND INDUCE PLAINTIFF TO PURCHASE THE SYSTEM. AT THE TIME THE PATIENT PURCHASED THE SYSTEM, THE PATIENT WAS UNAWARE OF THE CONCEALED OR SUPPRESSED FACTS AND WOULD NOT HAVE PURCHASED AND USED THE SYSTEM HAD THEY KNOWN THE FACTS. AS A RESULT OF THE FRAUDULENT CONDUCT OF THE DEVICE MANUFACTURER AS DESCRIBED ABOVE, THE PATIENT SUFFERED INJURIES CAUSED BY THE SYSTEM. THE PATIENT EXPERIENCED PERSONAL INJURIES, PAIN, SUFFERING, AND DISFIGUREMENT. DURING THE SURGICAL PROCEDURES TO IMPLANT THE SYSTEM INTO THE PATIENT, A MANUFACTURING REPRESENTATIVE WAS PRESENT TO INSTRUCT, AID, AND ADVISE THE PATIENT AND PATIENT¿S MEDICAL PROVIDERS REGARDING THE PROPER TECHNIQUES SUCH AS SELECTING A PUMP RESERVOIR SIZE, IMPLANTING THE DEVICE, CONNECTING THE DEVICE TO A CATHETER, CALCULATING MEDICATION DOSAGE AND DELIVERY RATE, CHOICE OF ADMINISTERING A BOLUS DOSAGE, AND PROPER DELIVERY OF MEDICATION INTO THE PUMP RESERVOIR. THE MANUFACTURING REPRESENTATIVE PRESENT DURING SELECTION AND/OR IMPLANTATION OF THE SYSTEM THEREBY TOOK A DUTY TO INSTRUCT AND ENSURE THAT THE SYSTEM WAS OPERATING PROPERLY AND THAT THE MEDICAL PROVIDERS USING THE DEVICE FOLLOWED PROPER PROCEDURES. THE DEVICE MANUFACTURER VOLUNTARILY ASSUMED DUTIES TO TRAIN MEDICAL PROVIDERS, INCLUDING THE PATIENT¿S MEDICAL PROVIDERS, TO USE THE SYSTEM FOR THE TREATMENT OF THE PATIENT¿S MEDICAL CONDITIONS. BY ASSUMING THIS DUTY, THE DEVICE MANUFACTURER HAD AN OBLIGATION TO THE PATIENT, AS PURCHASER AND END-USER OF THE SYSTEM, TO ENSURE THAT THE MANUFACTURING REPRESENTATIVES AND PATIENT¿S MEDICAL PROVIDERS WERE ADEQUATELY TRAINED, EDUCATED, AND/OR INSTRUCTED TO DETERMINE THE APPROPRIATENESS AND EFFICACY OF THE SYSTEM IMPLANTED IN THE PATIENT. THE DEVICE MANUFACTURER, THROUGH THEIR AGENTS, REPRESENTATIVES, SERVANTS, AND/OR EMPLOYEES, ACTING WITHIN THE COURSE AND SCOPE OF THEIR EMPLOYMENT, BREACHED THAT DUTY BY FAILING TO PROPERLY INSTRUCT THE MEDICAL PROVIDERS ON ONE OR MORE OF THESE ASPECTS OF PATIENT¿S IMPLANTATION SURGERY, AND BY FAILING TO ENSURE THE SYSTEM WAS OPERATING PROPERLY. AS A DIRECT AND PROXIMATE RESULT OF THE DEVICE MANUFACTURER'S BREACH OF DUTY, THE PATIENT SUFFERED INJURIES AND SUSTAINED DAMAGES. THE DEVICE MANUFACTURER FALSELY ADVERTISED THE EFFICACY AND SAFETY OF THE SYSTEM, INTENTIONALLY CONCEALED DANGEROUS CONDITIONS OF THEIR PRODUCT, AND CREATED THE FICTION OF A NEED FOR P PEOPLE TO USE THE SYSTEM. THE DEVICE MANUFACTURER¿S ACTIONS SHOWED A LACK OF GOOD FAITH, HONESTY IN FACT, AND OBSERVANCE OF FAIR DEALING, SO AS TO CONSTITUTE UNCONSCIONABLE COMMERCIAL PRACTICES. THE DEVICE MANUFACTURER ENGAGED IN FRAUDULENT BUSINESS PRACTICES TO ST IMULATE THE PROMOTION AND USE OF THEIR PRODUCTS AND GAIN AN UNFAIR ADVANTAGE OVER ALTERNATIVE TREATMENT FOR PAIN MANAGEMENT. THE PATIENT SUFFERED ASCERTAINABLE LOSS. THE PATIENT EXPERIENCED PHYSICAL INJURY, HOSPITALIZATION, AND UNDERWENT INTERIM MEDICAL TESTS INCIDENTAL TO THE PATIENT¿S USE OF A HARMFUL AND DEFECTIVE PRODUCT. THE DEVICE MANUFACTURER REPRESENTED THAT THE SYSTEM WAS SAFE FOR USE IN THE HUMAN BODY, AND FAILED TO DISCLOSE THAT THE SYSTEM RECEIVED BY THE PATIENT CONTAINED MANUFACTURING DEFECTS AND HAD BEEN MANUFACTURED IN VIOLATION OF FEDERAL REGULATIONS AND WAS "MISBRANDED" AND "ADULTERATED" WITHIN THE MEANING OF FEDERAL REGULATIONS. THE DEVICE MANUFACTURER COMMUNICATED THE FALSE AND MISLEADING STATEMENTS TO THE PUBLIC IN GENERAL AND SPECIFICALLY TO THE PATIENT, WITH THE INTENTION THAT THE PATIENT WOULD RELY ON THE STATEMENTS, AND IN CONNECTION WITH THE SALE OF THE SYSTEM. AS A DIRECT AND PROXIMATE RESULT OF THE DEVICE MANUFACTURER¿S VIOLATIONS, THE PATIENT BEEN DAMAGED. IT WAS NOTED THAT THE PATIENT WAS ELDERLY OR DISABLED. THE DEVICE MANUFACTURER MADE REPRESENTATIONS ABOUT THE SYSTEM THAT CONTAINED UNTRUE, DECEPTIVE OR MISLEADING REPRESENTATIONS WITH THE INTENT TO SELL OR DISPOSE OF THE DEVICE, IN THAT IT REPRESENTED THE DEVICE WAS FREE FROM MANUFACTURING DEFECTS AND MANUFACTURED IN COMPLIANCE WITH FEDERAL LAW. THE DEVICE MANUFACTURER FAILED TO DISCLOSE TO CONSUMERS IN GENERAL AND SPECIFICALLY THE PATIENT THAT THE FDA HAD DETERMINED THAT THE SYSTEM IMPLANTED IN THE PATIENT WAS "MISBRANDED" AND "ADULTERATED." THE DEVICE MANUFACTURER FAILED TO DISCLOSE TO CONSUMERS IN GENERAL AND SPECIFICALLY TO THE PATIENT THAT AT THE TIME THE DEVICES WERE MANUFACTURED, THAT THE FDA HAD DETERMINED AND THAT THE DEVICE MANUFACTURER ADMITTED, THAT THE DEVICE MANUFACTURER' S MANUFACTURING PLANTS WERE MANUFACTURING THE SYSTEM IN VIOLATION OF FDA REGULATIONS AND FEDERAL STATUTES. THE DEVICE MANUFACTURER MADE FALSE REPRESENTATIONS, AND FAILED TO DISCLOSE MATERIAL REPRESENTATIONS TO THE PUBLIC AND THE PATIENT WITH THE INTENT TO SELL THE SYSTEM TO THE PATIENT AND OTHERS; THEREBY CAUSING DAMAGES. THE DEVICE MANUFACTURER REPRESENTED TO THE PUBLIC IN GENERAL AND SPECIFICALLY THE PATIENT THAT THE SYSTEM IMPLANTED IN THE PATIENT WAS SAFE AND EFFECTIVE, AND MANUFACTURED WITHOUT DEFECTS IN COMPLIANCE WITH FEDERAL REGULATIONS. AT THE TIME THE DEVICE MANUFACTURER MADE THESE REPRESENTATIONS TO THE PUBLIC AND THE PATIENT, THE DEVICE MANUFACTURER KNEW THAT THE FDA HAD DETERMINED THAT T HE SYSTEM IMPLANTED IN THE PATIENT WAS MANUFACTURED IN VIOLATION OF FEDERAL REGULATIONS AND SPECIFICATIONS, INCLUDING REGULATIONS THAT GOVERN CGMP AND THAT THE FDA VIOLATIONS OF THE CGMP MEANT THAT THE DEVICE MANUFACTURER WAS UNABLE TO CONFIRM THAT THE SYSTEM IMPLANTED IN THE PATIENT WAS SAFE AND EFFECTIVE, FULLY CONFORMED TO SPECIFICATIONS, AND WAS FREE OF DEFECTS THAT COULD LEAD TO MALFUNCTIONS HAVING THE POTENTIAL TO CAUSE OR CONTRIBUTE TO SERIOUS BODILY INJURY; AND WAS MANUFACTURED AT A TIME WHEN THE SYSTEM WAS LABELED "ADULTERATED" AND "MISBRANDED". HAD THE PATIENT OR PATIENT¿S MEDICAL PROVIDERS KNEW OF THE DEVICE MANUFACTURER¿S MISREPRESENTATIONS ABOUT THE SYSTEM PRIOR TO ITS IMPLANTATION IN THE PATIENT, THE SYSTEM WOULD NOT HAVE BEEN PURCHASED BY THE PATIENT. DEFENDANTS RECEIVED INFORMATION THAT LONG TERM USE OF THE SYSTEM INCREASED THE LIKELIHOOD OF DRUG UNDER AND OVERDOSE, LEADING TO RESPIRATORY DEPRESSION, COMA OR DEATH AND POTENTIAL FOR ELECTRICAL SHORTING, LEADING TO A LOSS OF OR REDUCTION IN THERAPY, RESULTING IN SERIOUS ADVERSE HEALTH CONSEQUENCES INCLUDING DEATH AND OTHER INJURIES, BUT DESPITE THIS INFORMATION CONTINUED TO INTENTIONALLY FALSELY STATE THAT USING THE SYSTEM WAS SAFE. THE DEVICE MANUFACTURER FAILED TO ISSUE WARNINGS UNTIL THE INCIDENT RATE OF INJURY WAS SO HIGH. EVEN AFTER THAT TIME, THE DEVICE MANUFACTURER DOWNPLAYED THE ADVERSE EFFECTS OF THE SYSTEM, MISINFORMED, AND CONTINUED TO PROMOTE THE SYSTEM. SEE MFR REPORT 3007566237-2016-00491 AND 3004209178-2014-02818.
IT WAS REPORTED THERE WAS A VOLUME DISCREPANCY WHERE THE ACTUAL RESIDUAL VOLUME OF 7 WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME OF 3. IT WAS NOTED THIS DISCREPANCY WAS ALSO CONSISTENT WITH THE DISCREPANCIES OF PAST REFILLS. IT WAS NOTED THE PREVIOUS PROGRAMMING WAS CORRECT AND THE LOGS WERE NORMAL. IT WAS NOTED THE PATIENT HAD CONTINUED LOW BACK PAIN FOR THE PAST 6-8 MONTHS. IT WAS NOTED THE HEALTH CARE PROVIDER (HCP) DID NOT WANT TO INCREASE THE DOSE. IT WAS NOTED A DYE STUDY WAS PLANNED FOR (B)(6) 2014. THE PUMP WAS USED TO DELIVER DILAUDID. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 44009 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | Hospitalization| R| S |