FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3202916
·
Received July 2, 2013
Report
- Report Number
- 2182207-2013-00002
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- August 22, 2006
- Report Date
- March 28, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2000-(B)(6), (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS A MOTOR STALL AND MOTOR STALL RECOVERY NOTED IN THE PUMP LOGS. THE PATIENT DID NOT HEAR AN ALARM. THE STALL WAS CAUSED BY USING A TELEMETRY MAGNET FOR A PREVIOUS PUMP MANUFACTURER¿S PUMP MODEL. THE STALL BEGAN AT 10:37AM AND RECOVERED AT 10:49AM ON (B)(6)-2006 AFTER A REFILL. THERE WAS NO PATIENT TREATMENT, INTERVENTION, OR TROUBLESHOOTING REQUIRED OR PERFORMED. THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP WAS USED TO DELIVER COMPOUNDED BACLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302353 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00039 YR |