FDA Adverse Event
Malfunction
Summary report: N
ACTIVA
MDR report key: 2853465
·
Received November 30, 2012
Report
- Report Number
- 3004209178-2012-11020
- Event Type
- Malfunction
- Date Received
- November 30, 2012
- Report Date
- November 5, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- 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 STIMULATOR WENT INTO OVERDISCHARGE IN (B)(6), THOUGH IT WAS STATED TO HAVE BEEN 'SUCCESSFULLY RESOLVED.' EIGHT DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS 'DOING WELL.' NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES A VAILABLE.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A PROBLEM WITH HIS RECHARGER SYSTEM WHICH WAS THEN EXCHANGED. SINCE THEN, THERE HAVE BEEN "NO MORE PROBLEMS." IT WAS STATED THAT "THE PATIENT WAS ABLE TO RECHARGE WITHOUT ANY OTHER PROBLEMS." NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |