ACTIVA
Report
- Report Number
- 3004209178-2013-03471
- Event Type
- Malfunction
- Date Received
- March 8, 2013
- Report Date
- February 15, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- 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
(B)(4).
PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3389S-40, LOT# V078937, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V187428, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS "TURNING OFF ON IT'S OWN." IT WAS FURTHER REPORTED THAT OF THE PATIENT'S TWO INSS, "ONE TURNED OFF AND THE OTHER ONE DIDN'T." WHICH DEVICE SPECIFICALLY TURNED OFF WAS UNKNOWN AT THE TIME OF REPORT. IT WAS ALSO REPORTED THAT THIS HAD OCCURRED "TWICE." EACH EPISODE WAS REPORTED TO HAVE OCCURRED WHILE THE PATIENT WAS SEATED IN THE FRONT SEAT OF AN AUTOMOBILE. IT WAS UNKNOWN WHETHER THE CAR WAS TURNED ON AT THE TIME OF EACH EVENT. IT WAS ALSO REPORTED THAT THE PATIENT "FELT" HER INS TURN OFF AND WAS ABLE TO TURN IT BACK ON SUCCESSFULLY EACH TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98969 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |