FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3200108
·
Received July 1, 2013
Report
- Report Number
- 3007566237-2013-00980
- Event Type
- Malfunction
- Date Received
- July 1, 2013
- Date of Event
- April 30, 2008
- Report Date
- April 30, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. PHYSICIAN PRODUCT ID: 8709, SERIAL# (B)(4), PRODUCT TYPE: CATHETER. PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP HAD MOTOR STALL DUE TO THE HEALTH CARE PROVIDER USING THE MAGNET WHEN TRYING TO TELEMETRY THE PUMP. THE MOTOR STALL RECOVERY WAS NOTED IN THE EVENT LOGS 10 MINUTES AFTER MOTOR STALL. THERE WASN¿T ANY SYMPTOMS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299578 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00059 YR |