FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2972884
·
Received February 21, 2013
Report
- Report Number
- 3004209178-2013-02965
- Event Type
- Injury
- Date Received
- February 21, 2013
- Report Date
- January 28, 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
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
ANALYSIS OF THE PUMP REVEALED A FEED THROUGH ANOMALY WITH SHORTING ACROSS INSULATOR. THE PREVIOUSLY REPORTED CONCLUSION CODE NO LONGER APPLIES TO THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THIS PUMP WAS SCHEDULED FOR EXPLANT AS AN ALARM WAS GENERATED FOR A CONFIRMED MOTOR STALL. THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS AND INCREASED SPASTICITY AND THEREFORE WAS ADMINISTERED ORAL BACLOFEN. THE PATIENT WAS ON 3000 MICROGRAMS PER MILLILITER. IT WAS UNKNOWN HOW LONG THAT PATIENT HAD BEEN ON THIS CONCENTRATION. THIS DEVICE SYSTEM WAS THOUGHT TO HAVE DELIVERED COMPOUNDED BACLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75640 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |