FDA Adverse Event
Malfunction
Summary report: N
ACTIVA
MDR report key: 3143320
·
Received June 3, 2013
Report
- Report Number
- 9614453-2013-01068
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Report Date
- August 7, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 64002, SERIAL# UNKNOWN, IMPLANTED: 2012-(B)(6), PRODUCT TYPE ADAPTER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO NEW INFORMATION. THERE WAS NO X-RAY AND THE HCP DIDN¿T PLAN TO DO ANYTHING. IT WAS REPORTED THAT THE THERAPY WAS EFFECTIVE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A SHOCKING OR JOLTING SENSATION. IT WAS STATED THAT IT WAS ¿VERY RARE,¿ BUT THE PATIENT FELT A PARESTHESIA ¿LIKE AN ELECTROCUTION¿ FROM THE BREAST UP TO THE HEAD FOR 2 -3 SECONDS WHEN THE PATIENT TOUCHED THE IMPLANTABLE NEUROSTIMULATOR (INS) OR WHEN THE SEAT BELT PRESSED ON THE INS. IT WAS NOTED THAT AN X-RAY WAS TAKEN. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 245083 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | IPG MFG SWITZERLAND | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |