SYNCHROMED II
Report
- Report Number
- 3004209178-2013-11973
- Event Type
- Injury
- Date Received
- July 18, 2013
- Report Date
- June 25, 2013
- 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
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONCOMITANT PRODUCTS: CATHETER MODEL: 8578, LOT# N193015012, IMPLANTED: (B)(6) 2009, EXPLANTED: UNK; CATHETER MODEL: 8731, LOT# B006425N06, IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2013. (B)(4).
(B)(4).
(B)(4).
IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS AGO ON A SATURDAY THE PATIENT HAD SIGNS OF WITHDRAWAL, WENT INTO THE EMERGENCY ROOM, AND THEY TOOK HIM TO THE CLINIC THAT NEXT MONDAY. A CATHETER DYE STUDY WAS ATTEMPTED AND THEY¿RE UNABLE TO ASPIRATE THE CATHETER. AS OF THE DATE OF THIS REPORT PATIENT HAD A CATHETER REVISION. DURING THE PROCEDURE THE DISCONNECTED THE SPINAL SEGMENT TO SEE IF THERE¿S CSF (CEREBROSPINAL FLUID) AND ¿HE PUT IT RIGHT UP TO THE DISTAL TIP AND THE FIRST COUPLE OF BUMPS WERE OCCLUDED¿ PER THEIR OBSERVATION; ¿HE HAD IT IN FOR A REALLY LONG TIME¿. THE SURGEON WAS CONFIDENT THAT IT WAS OCCLUDED AND DIDN¿T WANT THE CATHETER ANALYSED. A NEW SPINAL SEGMENT WAS ADDED AND PRIMED. DUE TO SIGNS OF WITHDRAWAL PATIENT WAS THEN STARTED ON A LOW DOSE OF MORPHINE 20MG/ML 6.99MG/DAY AND BUPIVACAINE 14.9MG/ML 5.2MG/DAY. IT WAS LATER REPORTED THAT THE SURGEON HAD NOTED OCCLUSION AT THE CATHETER TIP, THE BOTTOM HOLES, AND HAD DISCARDED IT. A FAILED DYE STUDY WAS CONFIRMED. PATIENT OUTCOME WAS INDICATED AS RESOLVED WITHOUT SEQUELAE. IT WAS LATER REPORTED THAT ON (B)(6) 2013 PUMP WAS REPROGRAMMED, A TWO STEP WEAN PROCESS THAT INCLUDED DOSE DECREASE TO 4.5MG/DAY FOR 72 HRS AND THEN TO 2 MG/DAY.
ADDITIONAL INFORMATION LATER REPORTED THE CAUSE OF THE EVENT WAS OCCLUSION OF SPINAL PORTION OF THE CATHETER. THE CATHETER WAS EXPLANTED (B)(6) 2013 AND A NEW CATHETER IMPLANTED.
ADDITIONAL INFORMATION LATER RECEIVED REPORTED THAT PER THE PATIENT ¿A COUPLE OF TIMES MY PUMP QUIT WORKING AND WAS GOING THROUGH WITHDRAWALS¿ BUT THE ER/HOSPITAL WOULDN¿T HELP THEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 334181 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00059 YR | Required Intervention |