SYNCHROMED II
Report
- Report Number
- 3004209178-2014-12192
- Event Type
- Injury
- Date Received
- June 27, 2014
- Report Date
- April 17, 2017
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-1151-2008
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).
ANALYSIS OF THE CATHETER REVEALED A TEAR IN THE SEAL NEAR THE GUIDE RING OF THE SUTURELESS CONNECTOR, WHICH WAS DETERMINED TO BE NON-SIGNIFICANT.
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS LATER REPORTED THAT, WHILE LOOKING AT MRIS, THE PATIENT¿S HCP POINTED OUT A GRANULOMA GROWING AT THE TIP OF THE CATHETER. AT THE TIME OF THIS REPORT, THE PATIENT HAD A NEUROLOGIST WHO WOULD POSSIBLY HELP IN REMOVING THE GRANULOMA, IF THE PATIENT DID DECIDE TO GO FORWARD WITH THE OPERATION.
IT WAS REPORTED THAT THE PATIENT HAD AN INFLAMMATORY MASS. THE PATIENT REPORTEDLY HAD A SPINAL FUSION DONE ON (B)(6) 2014, AND AT THAT TIME, HE WAS TOLD THAT HE HAD A LARGE GRANULOMA. THE PUMP WAS BEING USED TO DELIVER INTRATHECAL MORPHINE. IT WAS LATER REPORTED THAT THE PATIENT DID NOT WANT TO SUE, ONLY TO BE FIXED. IT WAS NOTED THAT NO ONE WANTED "TO TOUCH" THE PATIENT WHEN IT CAME TO THE GRANULOMA WHICH REPORTEDLY SHOWED UP ON ALL 5 MRI'S WITH AND WITHOUT CONTRAST. THE PATIENT WAS REPORTEDLY "SCARED AS HECK". IT WAS NOTED THAT THE NEUROSURGEONS ALL REALIZED THAT THE PATIENT'S PUMP WAS ON THE RECALL LIST. THE PATIENT REPORTEDLY "ONLY MENTIONED MONEY AS HE FEARED THAT PARALYSIS OR DEATH AWAITS HIM." IT WAS NOTED THAT THE PATIENT, BEING FROM THE MILITARY, HAD NO FEAR OF DEATH.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS REFERRED TO A NEUROSURGEON FOR SURGICAL REMOVAL. NO ADDITIONAL INFORMATION WAS PROVIDED.
ADDITIONAL INFORMATION RECEIVED FROM A CONSUMER INDICATED THE PATIENT EXPERIENCED A CATHETER FAILURE (GRANULOMA) RESULTING IN INJURIES OF PARESTHESIA, OVERDOSE, HOSPITALIZATION, AND SURGERY.
IT WAS LATER REPORTED THAT THE PATIENT WAS DIAGNOSED WITH A GRANULOMA ON (B)(6) 2014. THE PATIENT EXPERIENCED SEVERE PAIN AT THIS TIME AND REPORTED THAT THE PUMP WAS TURNED OFF, ALTHOUGH THEIR RECORDS INDICATE IT WAS PROGRAMMED TO DELIVER 3.2 MG/ML OF MORPHINE. THE HCP HAD BEEN TITRATING THE PATIENT DOWN AND THEY PLANNED TO REPLACE THE PUMP AND CATHETER THE FOLLOWING WEEK. IT WAS NOTED THAT X-RAYS PERFORMED ON (B)(6) 2014 WERE NORMAL. OFFICE NOTES RECEIVED FROM (B)(6) 2014 INDICATED THE PATIENT HAD LUMBAR SPINE PAIN. THE PATIENT'S ORIGINAL PAIN WAS GONE AND THE ORIGINAL LEG PAIN WAS A LOT BETTER. ON AN OFFICE VISIT THAT TOOK PLACE ON (B)(6) 2014 THE PATIENT DESCRIBED BACK PAIN. THE PROBLEM WAS WORSENING AND OCCURRED PERSISTENTLY. THE LOCATION OF THE PAIN WAS LOWER BACK. THE PAIN WAS DESCRIBED AS AN ACHE. THE PATIENT'S SYMPTOMS WERE AGGRAVATED BY SITTING, STANDING AND WALKING. THE SYMPTOMS WERE RELIEVED BY PAIN MEDS/DRUGS. THE PATIENT WAS POSITIVE FOR BACK PAIN, MYALGIA. THE PAIN WAS DESCRIBED AS 9/10. THE PATIENT'S PAST HEALTH CARE PROFESSIONAL (HCP) WAS FILLING THE PATIENT'S PUMP WITH MORPHINE 20 MG CONCENTRATION WHICH HAD DISTAL ASPECT OF THE INTRATHECAL CATHETER. THE PATIENT REPORTED THAT THEIR PRIOR HCP SHUT OFF THE PUMP. IT WAS NOTED THAT THE PATIENT'S PUMP WAS ANALYZED ON TURNED BACK ON AND DECREASED FROM 20 MG PER ML TO 15 MG ML. THE PATIENT WAS SET UP FOR MRI OF THE THORACIC SPINE WITH/WITHOUT CONTRAST FOR FURTHER TREATMENT OR EVALUATION. IT WAS NOTED THAT THE PATIENT NEEDED MEDICATION TO FUNCTION. ON AN OFFICE VISIT THAT OCCURRED (B)(6) 2014 THE PATIENT PAIN SEVERITY WAS A 7. IT OCCURRED PERSISTENTLY AND THE LOCATION WAS LOWER BACK. THE PAIN WAS RADIATED TO THE RIGHT THIGH. THE SYMPTOMS WERE AGGRAVATED BY DAILY ACTIVITIES. THE PATIENT WAS POSITIVE FOR BACK PAIN AND MUSCLE WEAKNESS IN THE RIGHT LOWER EXTREMITIES. THE PATIENT WAS REFERRED FOR AN EVALUATION AND CATHETER REVISION. AN MRI WAS REVIEWED AND GRANULOMA WAS PRESENT. THE PATIENT WAS REFERRED FOR EVALUATION FOR REMOVAL OF GRANULOMA OR CATHETER REVISION. THE PUMP WAS CHANGED FROM MORPHINE TO DILAUDID DUE TO THE HISTORY OF GRANULOMA. THE PUMP WAS TURNED DOWN AND SURGERY WAS SCHEDULED. IT WAS NOTED THAT THE PATIENT HAD A CHANGE IN THERAPY EFFECT. THE PATIENT CAME INTO THE CLINIC ON THE DAY OF REPORT WITH SURGING FEELING OF WITHDRAWAL AND THEN INCREASED PAIN. THE PROBLEM STARTED 6 MONTHS PRIOR BUT STARTED GETTING WORSE THE END OF (B)(6). IT WAS REPORTED THAT PATIENT HAD A FEELING OF SURGES OF MEDICINE THEN WITHDRAWAL THAT STARTED THE FIRST PART OF (B)(6). THE PATIENT ALSO HAD DIARRHEA. THE PATIENT WAS REFILLED MOST RECENTLY ON (B)(6) THEY EXPECTED 6.8 ML AND REMOVED 9 ML. IT WAS REPORTED THAT ON (B)(6) 2014 A CT MYELOGRAM AND MRI WERE PERFORMED. THE PUMP HAD BEEN SWITCHED FROM MORPHINE TO DILAUDID AT A REFILL THAT OCCURRED (B)(6) 2014. RETURN PAPERWORK COMPLAINED OF WITHDRAWAL/OVERDOSE SYMPTOMS INTERMITTENTLY. IT WAS NOTED THAT THERE WAS NO PATIENT INJURY. IT WAS LATER REPORTED THAT THE PATIENT'S PUMP AND CATHETER WERE SUCCESSFULLY REPLACED ON (B)(6) 2014. THE PATIENT'S STATUS AFTER THE DEVICE REMOVAL WAS RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 378204 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00051 YR | Hospitalization| R |