SYNCHROMED II
Report
- Report Number
- 3004209178-2013-03647
- Event Type
- Injury
- Date Received
- March 13, 2013
- Date of Event
- November 1, 2008
- Report Date
- March 23, 2017
- 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
- ATTORNEY
Narratives
(B)(4).
(B)(4).
(B)(4).
PRODUCT ID NEU_PTM_PROG, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).
(B)(4)
ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT WAS "DOING GOOD". THE PATIENT WAS SCHEDULED TO MEET WITH THE MANUFACTURER REPRESENTATIVE TO REVIEW THE PERSONAL THERAPY MANAGER TECHNICAL REPORT IN TWO WEEKS OF THE DATE OF THIS REPORT.
IT WAS FURTHER REPORTED THAT THE PATIENT HAD REPORTED OVERDOSE AND WITHDRAWAL SYMPTOMS REPEATEDLY ATTRIBUTED TO THE PUMP. REPORTEDLY, THE PUMP WAS NOT WORKING CORRECTLY AS IT ¿ALWAYS¿ HAD A HIGH RESIDUAL VOLUME. THIS DID NOT MATCH THE PROGRAMMER READINGS. A ROTOR STUDY WAS DONE ON (B)(6) 2013 WITH NORMAL RESULTS. THE PATIENT UNDERWENT A REPLACEMENT PROCEDURE ON (B)(6) 2013 BUT DID NOT REQUIRE HOSPITALIZATION. THE PATIENT RECOVERED WITHOUT SEQUELAE.
ADDITIONAL INFORMATION RECEIVED REPORTED DURING PUMP REPLACEMENT (POSSIBLY (B)(6) 2013) THERE WAS A PARTIAL DISCONNECT, BUT IT WAS TAKEN CARE OF ALREADY. IT WAS FURTHER REPORTED THE PATIENT WOULD GET INTERMITTENT PAIN CONTROL AND FELT LIKE HE WAS NOT GETTING DRUG CONSISTENTLY. IT WAS UNKNOWN IF THE CATHETER WAS DISCONNECTED OR CUT NEAR THE PUMP CONNECTOR IN THE PUMP POCKET. THE LOCATION OF THE ISSUE WAS AT THE PUMP/CATHETER CONNECTOR. THE CATHETER WAS REVISED AND AN 8578SC PUMP CONNECTOR WAS ADDED TO REPAIR THE DAMAGED SECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.
IT WAS REPORTED THAT FOR THE PAST TWO YEARS, THIS PATIENT HAD BEEN STRUGGLING WITH THEIR THERAPY AND NOTED INTERMITTENT THERAPEUTIC EFFECT. THE PATIENT REPORTED GOING THROUGH PERIODS WHAT WOULD FEEL LIKE AN OVERDOSE AND THEN A WITHDRAWAL, HOWEVER, NOT BACK TO BACK. THERE WAS NO PARTICULAR PATTERN OR TIMEFRAME NOR DID THIS OCCUR NECESSARILY AFTER A REFILL OR BOLUS OR WAS RELATED TO CERTAIN EVENTS. IN (B)(6) THIS YEAR, A DYE STUDY WAS PERFORMED AND ALSO A ROLLER STUDY AT SOME POINT WITH NO EVIDENCE OF A MALFUNCTION. NO OTHER ERRORS OR BEEPING FROM THE PUMP WERE NOTED. THE PATIENT REPORTED "LIKE NOTHING HAD CHANGED." AT TIMES THE PATIENT REPORTED TO "FEEL THE DRUG" AROUND THEIR WAIST AND PUMP REGION. THE PATIENT STATED THAT ACTUAL VOLUMES WERE GREATER THAN EXPECTED VOLUMES. HOWEVER, IT WAS ALSO REPORTED THAT WHEN COMPARING THE ACTUAL AND RESIDUAL VOLUMES, THESE WOULD MATCH WITHIN ABOUT SEVEN PERCENT OR THEY WERE VERY CONSISTENT. WHEN THE PUMP "WORKS" THE PATIENT REPORTS GETTING THEIR LIFE BACK. THIS PATIENT WAS VERY ACTIVE WITH WORK AND FAMILY LIFE AND NO NEW ACTIVITIES WERE PRESENT IN THE PATIENT'S LIFE. THE PATIENT THOUGHT THE PERSONAL THERAPY MANAGER (PTM) WAS NOT WORKING. THIS DEVICE SYSTEM WAS USED TO DELIVER FENTANYL AND BUPIVACAINE. IT WAS LATER REPORTED THAT THE PHYSICIAN DECLINED AN INDIUM STUDY FOR FURTHER TROUBLESHOOTING AT THIS POINT. THERE WERE OTHER ISSUES, WHICH WERE NOT PROVIDED, TO BE FURTHER DISCUSSED WITH THE PATIENT. AT THAT TIME THE PATIENT'S THERAPY WAS WORKING AND THERE WERE NO FURTHER INTERVENTIONS PLANNED. FURTHER REPORTED, THE PATIENT HAD BEEN LOCKED OUT AT INAPPROPRIATE TIMES. THE BEFORE MENTIONED INCONSISTENT THERAPY NOW WAS REPORTED TO HAVE OCCURRED ONCE EVERY THREE MONTHS. NO MOTOR STALLS WERE SEEN ON THE PUMP LOGS. AFTER FURTHER REVIEWING THE LOGS, IT WAS NOTED THAT THE PATIENT RECEIVED BOLUSES, HOWEVER WHEN THE BOLUSES WERE DENIED IT WAS DUE TO ONE OF THE STANDARD LOCKOUTS RELATED TO HOW THE PATIENT'S PUMP HAD BEEN PROGRAMMED. AGAIN, NOTHING ON THE LOGS HAD INDICATED A MALFUNCTION. THE PHYSICIAN ELECTED TO ADJUST THE DOSE RESTRICTION INTERVAL AND WOULD MONITOR THE PATIENT AS THE ISSUES HAD NOT BEEN CONSISTENT AND VERY DIFFICULT TO PIN POINT. THE PATIENT WOULD BE SEEN IN TWO WEEKS TO EVALUATE IF THE LOCK OUT ISSUES RESOLVED. THE DEVICES WERE REPORTED TO HAVE BEEN WORKING APPROPRIATELY.
PER REPORTER THE PUMP WAS REPLACED IN "(B)(6) 2013". AT THAT PUMP REPLACEMENT, THEY NOTED A CUT/TEAR AT SC CONNECTOR. AT THAT TIME, THE PATIENT HAD SYMPTOMS THAT SEEMED TO EQUATE WITH THE CUT/TEAR.
IT WAS FURTHER REPORTED THAT THERE WAS A CHANGE IN THE THERAPY EFFECT AS THE PATIENT CONTINUED TO REPORT FEELING BEING UNDERDOSED AND OVERDOSED AT TIMES. THE PHYSICIAN REPORTED LARGE DISCREPANCIES BUT REPORTEDLY THESE HAVE BEEN WITHIN PUMP SPECIFICATION. A DYE STUDY HAD NOT SHOWN ANY ISSUES. THE SYSTEM WAS TO BE REVISED ON (B)(6) 2013. HOWEVER, THE PHYSICIAN WAS UNSURE WHAT WOULD BE REVISED. THE PATIENT AND HEALTH CARE PROVIDER REPORTEDLY FELT THERE WAS A PROBLEM WITH THE PUMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
AN ATTORNEY ALLEGED THAT THE PATIENT BEGAN TO HAVE COMPLICATIONS SHORTLY AFTER THEIR PUMP AND CATHETER WERE IMPLANTED. WHILE MAKING A TRIP TO (B)(6), THE PATIENT SUDDENLY BECAME VERY ILL. THEY WERE COMPLETELY BEDRIDDEN FOR NEARLY TWO WEEKS IN (B)(6). WHEN THEY RETURNED HOME, THE ILLNESS CONTINUED, AND THE PATIENT BEGAN TO SEE MEDICAL ATTENTION. THE ILLNESS OFTEN TOOK FOUR TO FIVE DAYS AWAY OF PRODUCTIVE LIFE FROM THE PATIENT¿S WEEK. THIS WAS THE COMMENCEMENT TO YEARS OF CONSISTENT EPISODES THAT BEGAN WITH SEVERE HOT FLASHES WHICH PROGRESSES TO ABDOMINAL CRAMPING, NAUSEA, SEVERE MALAISE, AND FATIGUE. DURING THESE EPISODES, THE PATIENT COMPLAINED THAT EVEN DRINKING WATER MADE THEM FEEL NAUSEOUS. AFTER THE EPISODE WAS IN FULL SYMPTOMOLOGY THE PATIENT COMPLAINED OF BLURRED VISION. DURING THESE EPISODES THE PATIENT WAS SO SEVERELY COMPROMISED THAT IT WOULD TAKE A LONG TIME TO GAIN THE SELF-MOTIVATION TO GET UP AND MOVE SIX FEET INTO THEIR BATHROOM. ON (B)(6) 2009, THE PATIENT WAS TOLD BY HIS HEALTHCARE PROVIDER THAT THEY WERE LOOKING FOR A RARE TUMOR NAMED PHEOCHROMOCYTOMA OR A MORE ELUSIVE EXTRA-ADRENAL PARAGANGLIOMA THAT MAY HAVE BEEN AFFECTING THEIR ADRENAL GLAND. AFTER MANY MONTHS OF TESTING, A FINAL NUCLEAR STUDY THAT INCLUDED A MULTI-HOUR FULL BODY SCAN FOR FOUR DAYS IN A ROW DETERMINED THAT THERE WAS NO TUMOR. TWO YEARS LATER, THE PATIENT REQUESTED THAT THE MORPHINE BE REMOVED FROM THE PUMP AND REPLACED WITH HYDROMORPHONE (DILAUDID) OR FENTANYL. THIS TOOK SEVERAL WEEKS TO ARRANGE, BUT ONCE THE MORPHINE STOPPED BEING ADMINISTERED, THE LEVEL OF ILLNESS SOMEWHAT LESSENED, THOUGH IT WAS STILL VERY MUCH PRESENT. THE PATIENT NOTICED THAT THE SYMPTOMS THEY WERE SUFFERING BEGAN TO FEEL LIKE A WITHDRAWAL AND OVERDOSE CYCLE. THIS TOOK MORE AND MORE OF HIS PRODUCTIVE LIFE AWAY. IN THE SPRING OF 2013, THE PATIENT¿S PUMP AND CATHETER WERE REPLACED WITH NO SURGICAL COMPLICATIONS. THE POSTOPERATIVE DIAGNOSIS WAS A ¿FAILED INTRATHECAL PAIN PUMP AND FAILED INTRATHECAL CONNECTOR/PARTIAL CATHETER¿. THE DOCTOR NOTICED A DISINTEGRATION OF THE PLASTIC PIECE, INCLUDING BROKEN PIECES, AROUND THE CONNECTOR SITE GOING INTO THE PUMP. THEY ALSO DESCRIBED A SLIGHT LEAKAGE OF MEDICATION AND CLEAR FLUID AROUND THE CONNECTION SITE. IT WAS POSTULATED THAT THE LEAKAGE CAUSED THE MORPHINE, AND LATER FENTANYL, TO FLOW INTO THE SCAR POCKET WHERE THE PUMP WAS LOCATED. DURING THIS PERIOD, IT WAS THOUGHT THAT THE PATIENT WOULD HAVE EXPERIENCED WITHDRAWAL SYMPTOMS. THEN, AT RANDOM TIMES, AND OFTEN WAKING THE PATIENT FROM A SLEEPING AID INDUCED SLEEP, THE NARCOTIC FOUND A WAY OUT OF THE SCAR POCKET AND FLOODED THEIR ABDOMINAL CAVITY. DURING THIS TIME THEY EXPERIENCED VARIOUS LEVELS OF OVERDOSE SYMPTOMS, WHICH CAUSED THE PATIENT TO BECOME SEVERELY ILL. THE PATIENT SPENT FIVE AND A HALF YEARS BATTLING THE EFFECTS OF THE DEFECTIVE DEVICE. THE PATIENT HAD REPORTEDLY LAID IN BED CRYING FROM THE PAIN. THE MANUFACTURER REPORTEDLY PROVIDED DEFECTIVE MEDICAL DEVICES WHICH THE PATIENT UTILIZED AND THEREBY SUFFERED SERIOUS AND PERMANENT PERSONAL INJURIES. THE PATIENT SUFFERED AND WILL CONTINUE TO SUFFER DAMAGES, INCLUDING LOST WAGES AND BENEFITS, DIMINISHED WAGES AND FUTURE EARNINGS, MENTAL ANXIETY AND ANGUISH, DISFIGUREMENT, LOSS OF SELF-ESTEEM, AND MEDICAL BILLS.
ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER REPORTED THAT FOR FIVE YEARS STARTING IN 2008 FOUR TO FIVE DAYS A WEEK THE PATIENT WAS LEFT WITH BLURRED VISION, UNABLE TO WALK, AT TIMES ABDOMINAL PAIN, AND NAUSEA SO SEVERE THE PATIENT COULD NOT EAT OR DRINK. IT WAS REPORTED THE PATIENT'S SYMPTOMS, WERE CONSISTENT WITH WITHDRAWAL/OVERDOSE CYCLES WITH OPIOID MEDICATION, WERE CAUSED BY THE DEVICE THAT STOPPED WORKING PROPERLY AND FAILED TO DELIVER MEDICATION AS PROGRAMMED BY THE PROVIDERS. ON (B)(6) 2013 THE PATIENT UNDERWENT SURGICAL REMOVAL AND REPLACEMENT OF THE PUMP SYSTEM. DURING THE REPLACEMENT SURGERY THE PHYSICIAN NOTICED DISINTEGRATION OF A MATERIAL PIECE CONNECTING THE PUMP AND CATHETER, AND MANY BROKEN CATHETER/CONNECTOR PIECES AROUND THE CONNECTOR SITE GOING INTO THE PUMP. THE PATIENT RECORDS ALSO DESCRIBED MEDICATION AND FLUID LEAKAGE AROUND THE PUMP-CATHETER CONNECTION SITE. THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE LEAKAGE CAUSED THE MEDICATION TO FLOW FROM THE PUMP DIRECTLY INTO A POCKET WHERE THE PUMP IS LOCATED. THE PATIENT'S ILLNESS WAS CAUSED BY CYCLES OF A PUMP-INDUCED MEDICATION OVERDOSE AND UNDERDOSE. MEDICATION AT RANDOM TIMES WOULD LEAK OUT OF THE COMPROMISED CONNECTION BETWEEN THE PUMP AND CATHETER OF THE INFUSION SYSTEM AND THE PATIENT WOULD EXPERIENCE OVERDOSE SYMPTOMS CAUSING HIM TO BECOME SEVERELY ILL, AFTER WHICH THE PUMP WOULD BE EMPTY AND THE PATIENT WOULD BECOME DEBILITATING ILL DUE TO WITHDRAWAL SYMPTOMS. IT WAS CLARIFIED THAT THE PATIENT'S CATHETER HAD IN FACT FRACTURED AND LEAKED CAUSING SEVERE PAIN AND EXTENDED HOSPITALIZATION. IT WAS NOTED THE CAUSE OF THE PATIENT'S INJURIES WERE WHEN THE CONNECTOR, CATHETER, AND IT'S COMPONENTS BECAME DISLODGED AFTER IT SURGICAL IMPLANTATION, PREVENTING PROPER DELIVERY OF MEDICATION. DUE TO THE DEVICE MALFUNCTION MEDICATION DID NOT REACH THE TREATMENT SITE, WHICH REQUIRED PREMATURE REMOVAL OF THE FAILED PUMP SYSTEM AND SIGNIFICANT INJURIES EXPERIENCED DURING OVERDOSE AND WITHDRAWAL CYCLES LASTING ALMOST FIVE YEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105634 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00049 YR | Required Intervention |