INTERSTIM
Report
- Report Number
- 9614453-2013-00567
- Event Type
- Injury
- Date Received
- March 20, 2013
- Report Date
- March 5, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4)
FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: THE INS WAS RECEIVED WITH NO TELEMETRY AND NO OUTPUT. DESTRUCTIVE ANALYSIS OF THE INS FOUND THAT THE BATTERY WAS DEPLETED. NO VISUAL OR ELECTRICAL ANOMALIES WERE FOUND WITH THE HYBRID CIRCUIT. NO PARAMETER HISTORY WAS GIVEN, EXCEPT TO SAY THAT THE PARAMETERS WERE HIGH, SO THE EXPECTED LIFE COULD NOT BE DETERMINED. BASED ON THE ANALYSIS OF THE INS, THE BATTERY REACHED A NORMAL END-OF-LIFE CONDITION.
(B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION AND THE PATIENT'S NEUROSTIMULATOR WAS REPLACED. IT WAS REPORTED THAT THERE WERE NO PATIENT INJURIES RELATED TO THE EVENT.
IT WAS LATER REPORTED ON 2013-(B)(6) THAT THERE WAS NO TROUBLESHOOTING PERFORMED SINCE THEY COULDN'T COMMUNICATE WITH THE STIMULATOR DUE TO BATERY DEPLETION. PATIENT OUTCOME WAS OK, HER STIMULATOR WAS REPLACED BUT THE STIMULATION DOESN'T SEEM TO BE EFFECTIVE ANYMORE. THE PROGRAMMED PARAMETERS WERE VERY HIGH, AT 6VOLT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115732 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | IPG MFG SWITZERLAND | 3023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |