FDA Adverse Event
Malfunction
Summary report: N
ACTIVA
MDR report key: 2911825
·
Received January 11, 2013
Report
- Report Number
- 3007566237-2013-00129
- Event Type
- Malfunction
- Date Received
- January 11, 2013
- Report Date
- December 18, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MRU
- PMA / PMN Number
- H020007
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S DEVICE TURNED OFF TWICE ON TWO DIFFERENT OCCASIONS DUE TO TEMPERATURES OVER 100 DEGREES THIS PAST SUMMER. THE PATIENT EXPERIENCED A RETURN OF DYSTONIA SYMPTOMS WHEN THAT HAPPENED. HOWEVER, ONCE THE DEVICE WAS TURNED BACK ON IN BOTH INSTANCES, THE PATIENT WAS REPORTEDLY FINE. THERE WERE NO OTHER REPORTS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) SHUTTING OFF. THE PATIENT WAS DOING WELL AND THE DEVICE REMAINED IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION INDICATED THAT THE DEVICE TURNING OFF SCENARIO OCCURRED AT LEAST 2 TIMES, SEVERAL MONTHS APART.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17725 | ACTIVA | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) | MRU | MEDTRONIC NEUROMODULATION | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |