ACTIVA
Report
- Report Number
- 3007566237-2013-00319
- Event Type
- Malfunction
- Date Received
- January 30, 2013
- Date of Event
- January 9, 2013
- Report Date
- August 15, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
(B)(4).
(B)(4).
IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR SWITCHED OFF WITHOUT APPARENT REASON. THERE WAS A LOSS OF STIMULATION AND THERAPEUTIC EFFECT. IT WAS REPORTED THAT THE PATIENT HAD TO GO TO THE EMERGENCY ROOM TO GET THE STIMULATOR TURNED BACK ON. IT WAS NOTED THAT THIS HAD HAPPENED FOR THE SECOND TIME IN THE PAST THREE MONTHS. IT WAS UNKNOWN WHAT THE FIRST TIME REFERRED TO. IT WAS REPORTED THAT THE PATIENT'S WIFE WAS "AFRAID" TO USE THE PATIENT PROGRAMMER AND "DIDN'T DARE" TURN ON THE DEVICE BY HERSELF. IT WAS NOTED THAT THERE WERE NO APPARENT ELECTROMAGNETIC INTERFERENCE SOURCES AROUND, AND AT THE TIME OF THE INCIDENT THE PATIENT WAS AT HOME WATCHING TELEVISION AS HE DID REGULARLY. PATIENT SYMPTOMS INCLUDED STRONG TREMOR DUE TO LOSS OF STIMULATION. THE PATIENT SUFFERED NO INJURY OR ADVERSE EVENT AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION INDICATED THAT THERE WAS NO RECORD FOR THE FIRST INCIDENT. ONLY THE SECOND OCCURRENCE WAS PREVIOUSLY REPORTED. THERE WAS NO TROUBLESHOOTING DONE.
IT WAS NOTED THAT THE PATIENT WAS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 41193 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | 37612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |