FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1111660
·
Received August 13, 2008
Report
- Report Number
- 3004209178-2008-04905
- Event Type
- Malfunction
- Date Received
- August 13, 2008
- Date of Event
- January 1, 2008
- Report Date
- July 15, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT RECENTLY HAD HER BLADDER REMOVED DUE TO A RARE FORM OF BLADDER CANCER. THE PT IS NOT WELL ENOUGH TO HAVE DEVICE REMOVED, SO IT REMAINS IMPLANTED. THE DEVICE HAD BEEN TURNED OFF BUT IT HAD TURNED ON BY ITSELF TWICE. IT HAPPENED ONCE IN THE GROCERY STORE AND ONCE AT HOME. THE PT IS AT HOME AND IN GOOD CONDITION. FURTHER INFO IS BEING REQUESTED FROM THE HCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | EXPLANTED| PROGRAMMER MODEL 3031A LOT# NGM017605P| EXTENSION MODEL 3095 LOT# NAH018602V| IMPLANTED |