SYNCHROMED II
Report
- Report Number
- 3007566237-2013-02455
- Event Type
- Injury
- Date Received
- July 23, 2013
- Date of Event
- July 1, 2012
- Report Date
- June 28, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-1150-2008
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN. PRODUCT TYPE: CATHETER. (B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8703W, LOT# L36578, IMPLANTED: (B)(6) 1995, PRODUCT TYPE: CATHETER. (B)(4).
(B)(4)
ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTH CARE PROVIDER (HCP) HAD TRIED EVERYTHING TO RESOLVE THE GRANULOMA THAT WAS BETWEEN T8 AND T10 FOR OVER A YEAR. THE HCP HAD EMPTIED AND RINSED THE PUMP TO FILL IT WITH SALINE. HE HAD TURNED IT TO MINIMUM RATE AND RAN IT. A WHOLE YEAR LATER AFTER THE REPEATED MRIS TO CHECK THE PROGRESS, THE GRANULOMA AS PREVIOUSLY REPORTED HAD NOT SHRUNK AT ALL. THE HCP HAD SENT THE PATIENT TO A NEUROSURGEON FOR EVALUATION. IT WAS NOTED THE CATHETER HAD BEEN IN PLACE FOR ABOUT FIFTEEN YEARS AND IT WAS DECIDED THAT OPENING UP THE DURA AND TRYING TO DETACH THE CATHETER FROM THE GRANULOMA OR REMOVE THE CATHETER WAS NOT WORTH THE RISK. THE CATHETER WAS CLEARED, ABANDONED AND CAPPED. ONLY THE PUMP WAS EXPLANTED AND DISPOSED OF. IT WAS NOTED THE PATIENT HAD BEHCET'S SYNDROME (CIDP) AND SHE WAS NOT 100% COMPLIANT OR RELIABLE. HER MENTAL CAPACITY/COGNITIVE FUNCTION WAS ¿JUST NOT THERE¿ AND THE PATIENT TENDED TO REPEAT THINGS OVER AND OVER. THE HCP HAD NO FURTHER INFORMATION TO PROVIDE ABOUT THE EVENT, NOTHING NEW HAD HAPPENED. THE PATIENT DID NOT RECEIVE A NEW DEVICE AND WAS CURRENTLY BEING MANAGED WITH ORAL MEDICATION.
IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) BELIEVED THE PATIENT MAY HAVE HAD A GRANULOMA. THE HCP WAS ATTEMPTING TO IDENTIFY THE GRANULOMA ON THE CATHETER TIP UNDER CT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS LATER REPORTED THAT THE PATIENT HAD A PUMP REFILL IN (B)(6) 2012 AND TOLD THE HCP THAT SHE WAS HAVING SCIATIC PAIN IN HER LEGS. IT WAS NOTED THAT THE PATIENT HAD MAJOR SURGERY 7-8 YEARS PRIOR TO THE REPORT DUE TO THE SCIATIC PAIN. THE PATIENT WAS SENT FOR AN MRI AND A GRANULOMA WAS FOUND ON THE HEAD OF THE CATHETER. THE HCP TOLD THE PATIENT SHE WOULD HAVE TO PART WITH HER PUMP AND THAT SHE WOULD NOT GO THROUGH WITHDRAWAL BECAUSE SHE WAS ON A LOW DOSE OF MEDICATION. THE PATIENT NOTED THAT THE HCP HAD BEEN LOWERING THE DOSE FOR 2 YEARS SO SHE DID NOT HAVE TO GO THROUGH WITHDRAWAL. SALINE WAS PUT IN THE PATIENT'S PUMP IN (B)(6) 2012. SINCE (B)(6) 2012 THE PATIENT HAD 5 MRIS WITH THE MOST RECENT BEING A COUPLE WEEKS PRIOR TO THE REPORT. THE PATIENT STATED THAT THE SIZE OF THE GRANULOMA HAD NOT DECREASED. A SURGEON TOLD THE PATIENT TO WAIT 6 MONTHS THEN HE WOULD REMOVE THE GRANULOMA; HOWEVER, THE SURGEON NOW SAID THAT HE WOULD NOT TOUCH THE GRANULOMA SINCE IT WAS "TOUCHING EVERY PART OF HER SPINE". IT WAS NOTED THAT DUE TO THE PATIENT'S PAST INJURIES AND MEDICAL CONDITIONS SHE HAD BEEN ON A LOT OF PAIN MEDICATIONS. THE PATIENT WAS TAKING METHADONE "AROUND THE CLOCK...EVERY 3 HOURS...HAS BEEN ON THIS FOR 12-13 YEARS". THE DEVICE SYSTEM HAD PREVIOUSLY DELIVERED MORPHINE BUT CURRENTLY CONTAINED SALINE. IT WAS LATER REPORTED THAT THE PATIENT HAD EXPERIENCED SOME INCREASE IN PAIN AND RADICULAR SYMPTOMS. THE GRANULOMA WAS CONFIRMED AT T8. SEVERAL MRIS DID NOT DOCUMENT ANY RESOLUTION OF THE GRANULOMA. THE PUMP WAS WEANED OFF, STOPPED AND REFILLED WITH SALINE. THE PUMP HAD BEEN OFF SINCE (B)(6) 2012. IT WAS NOTED THAT THE CATHETER HAD BEEN IN PLACE FOR MANY YEARS.
IT WAS LATER REPORTED THAT THE PUMP HAD BEEN ALARMING ON AND OFF FOR APPROXIMATELY 1 WEEK PRIOR TO THE REPORT. THE PATIENT STATED THE ALARM WENT OFF THE NIGHT BEFORE LAST AND THE ALARM WAS VERY IRREGULAR "NOT LIKE AN ALARM IN THE PAST". THE PATIENT STATED THAT HER SCIATIC PAIN BECAME SO EXTREME TO THE POINT WHERE SHE COULD NOT WALK. THE PATIENT CONSIDERED GETTING AN ELECTRIC WHEELCHAIR OR SCOOTER BECAUSE SHE COULD NOT SIT VERY LONG AND ONLY LAY ON HER RIGHT SIDE FOR RELIEF. IN REGARDS TO THE GRANULOMA, THE PATIENT'S PERSONAL OPINION WAS THAT THE PUMP WAS "LEAKING OVER THE EDGE FROM LOOKING AT THE X-RAY THAT THE HCP SHOWS". THE PATIENT WAS CURRENTLY SEEKING A NEW PHYSICIAN.
IT WAS LATER REPORTED THAT THE SCIATICA RETURNED "SEVERAL MONTHS AGO IN (B)(6)". THE PATIENT STATED "SUPPOSEDLY THE DOCTOR TURNED MY ALARM OFF BEFORE HE LEFT BUT NOW IT'S ALARMING, AND THERE IS NOTHING IN IT JUST SALINE". THE PATIENT STATED THE ALARM HAD "BEEN GOING OFF FOR WEEKS AND THE DOCTOR TURNED IT OFF, BUT IT STILL GOES OFF 10 TIMES A DAY". THE PATIENT STATED THAT NO DOCTOR WOULD TOUCH HER BECAUSE THE GRANULOMA WAS SO LARGE. THE PATIENT STATED THAT HER DOCTOR WOULD NOT SEE HER FOR 6 MONTHS AND THEN SAID HE "WOULDN'T TOUCH IT". THE PATIENT STATED THE MEDICATION WAS "DRIPPING OVER THE CATHETER THAT CAUSED MY PROBLEM". THE CATHETER COULD NOT BE TAKEN OUT BECAUSE THE GRANULOMA WAS SO LARGE AND THE HEALTHCARE PROVIDER THOUGHT IT WOULD PARALYZE THE PATIENT. THE PATIENT STATED THAT THE PUMP WAS TO BE REMOVED ON "THE (B)(6)" BUT WAS VERY WORRIED ABOUT LOSING SPINAL FLUID AND "GETTING REALLY UGLY HEADACHES".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342871 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00066 YR | Other| R |