FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3200103
·
Received July 1, 2013
Report
- Report Number
- 3007566237-2013-00969
- Event Type
- Malfunction
- Date Received
- July 1, 2013
- Date of Event
- December 13, 2007
- Report Date
- December 13, 2007
- 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
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A MOTOR STALL OCCURRED AND RECOVERED. THE MOTOR STALL LASTED FIVE MINUTES. THE STALL WAS CAUSED BY THE HEALTHCARE PROVIDER (HCP) USING A MAGNET WHILE INITIATING TELEMETRY WITH THE PUMP. THERE WERE NO PATIENT SYMPTOMS RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298250 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00023 YR |