FDA Adverse Event
Injury
Summary report: N
ACTIVA
MDR report key: 3231320
·
Received July 17, 2013
Report
- Report Number
- 9614453-2013-01484
- Event Type
- Injury
- Date Received
- July 17, 2013
- Report Date
- June 25, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS A POSSIBLE REJECTION OF THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THE INS HAD BECOME ¿TOO SUPERFICIAL¿ AND ON (B)(6) 2013, A REVISION WAS DONE TO PREVENT THE SYSTEM FROM ERODING THROUGH THE SKIN BY IMPLANTING IN OPPOSITE SIDE OF THE CHEST. IT WAS STATED AS THE INS WAS BEING REVISED, THE INS POCKET SHOWED PUS. ADDITIONAL INFORMATION STATED THE PATIENT WAS OK AFTER THE REVISION AND THE INS WAS RE-IMPLANTED IN THE OPPOSITE SUBCLAVICULAR POCKET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331598 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | IPG MFG SWITZERLAND | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |