FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3200072
·
Received July 1, 2013
Report
- Report Number
- 3007566237-2013-01033
- Event Type
- Malfunction
- Date Received
- July 1, 2013
- Report Date
- June 7, 2007
- 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 THE PUMP MOTOR STALL OCCURRED WHEN THE HEALTH CARE PROVIDER TRIED TO USE MAGNET TO INTERROGATE THE PUMP. AN MOTOR STALL ERROR DISPLAYED. THERE WAS NOT PATIENT SYMPTOM REPORTED. THE PATIENT OUTCOME WAS UNKNOWN. THE DRUG IN THE SYSTEM WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299571 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |