FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3103369
·
Received May 9, 2013
Report
- Report Number
- 3004209178-2013-07486
- Event Type
- Injury
- Date Received
- May 9, 2013
- Report Date
- April 15, 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
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WENT THROUGH WITHDRAWAL SYMPTOMS DUE TO PATIENT BEING TAKEN OFF ORAL BACLOFEN 'COLD TURKEY' BEFORE PROCEDURE. THE PATIENT WAS SENT TO A REHABILITATION HOSPITAL AFTER IMPLANT. THE PATIENT WAS DISSATISFIED WITH THE SURGEON AND WAS FILING A 'FORMAL COMPLAINT' AGAINST HIM. IT WAS LATER REPORTED THAT THE CAUSE OF THE WITHDRAWALS WAS A PUMP MOTOR STALL AND THE PUMP WAS REPLACED. THE PUMP WAS DELIVERING LIORESAL. IT WAS LATER REPORTED THE PUMP WAS DELIVERING GABLOFEN AND THE CAUSE OF THE EVENT WAS POST OPERATIVE BACLOFEN WITHDRAWAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203751 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00049 YR | Required Intervention |