FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3202935
·
Received July 2, 2013
Report
- Report Number
- 3007566237-2013-01030
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Report Date
- June 6, 2005
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A MOTOR STALL OCCURRED DURING INTERROGATION. IT WAS CONFIRMED THAT THE HEALTH CARE PROVIDER USED A MAGNET TO INTERROGATE THE PUMP, AND THE PUMP HAD RECOVERED. THERE WAS NOT PATIENT SYMPTOM REPORTED AND THE PATIENT OUTCOME WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302845 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |