FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 4243491
·
Received November 11, 2014
Report
- Report Number
- 3007566237-2014-03293
- Event Type
- Injury
- Date Received
- November 11, 2014
- Report Date
- November 5, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. PRODUCT ID 37761, LOT# C0409640, PRODUCT TYPE RECHARGER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE RECHARGER WAS BROKEN AND THERE WAS A COMMUNICATION/TELEMETRY ISSUE. A COUPLING ISSUE WAS ALSO REPORTED AND THE RECHARGER WAS NO LONGER CHARGING THE IMPLANTABLE NEUROSTIMULATOR (INS). THE INS HAD FLIPPED OVER. ONCE THE INS WAS REPOSITIONED THE PROBLEM WAS RESOLVED AND THE PATIENT WAS RECEIVING ADEQUATE THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 727562 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |