FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 1063675
·
Received June 19, 2008
Report
- Report Number
- 3004209178-2008-03365
- Event Type
- Malfunction
- Date Received
- June 19, 2008
- Date of Event
- May 1, 2007
- Report Date
- May 20, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD AN INTERSTIM IMPLANTED ON HER RIGHT SIDE AND IT STOPPED WORKING A FEW MONTHS AFTER IMPLANT. THE PATIENT'S IPG WAS PROTRUDING FROM HER BOTTOM DUE TO HER THIN BODY AND IT WAS DISCOVERED THAT THE LEAD WAS "BAD". THE IPG WAS REPOSITIONED DEEPER IN HER BODY AND THE LEAD WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PROGRAMMER MODEL 3037 LOT# NJD033921N| LEAD MODEL 3093 LOT# V011895| IMPLANTED| EXPLANTED |