FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1220435
·
Received October 31, 2008
Report
- Report Number
- 3004209178-2008-07095
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Date of Event
- January 1, 2007
- Report Date
- September 30, 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
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS ORIGINALLY REPORTED THAT THE PATIENT FELL OVER A YEAR AGO. SINCE THE FALL ,THE PATIENT HAS HAD A LOSS OF THERAPEUTIC EFFECT. SHE COULD BARELY FEEL THE STIMULATION AND WAS HAVING THREE URINARY ACCIDENTS A DAY. SHE WAS AT HOME IN FAIR CONDITION. THE HEALTHCARE PROVIDER CONFIRMED THAT THE PATIENT EXPERIENCED NO STIMULATION AND THAT FOLLOWING A FALL, THE DEVICE STOPPED WORKING. SHE ALSO EXPERIENCED FLANK PAIN. THE PATIENT'S DEVICE WAS REPROGRAMMED AND THERE WAS AN IMPROVEMENT IN SENSATION. IT WAS REPORTED THAT THE LACK OF EFFECT IS NOT RELATED TO THE DEVICE, THE PATIENT'S INCONTINENCE HAS WORSENED DUE TO STRESS. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention | IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 3095| EXPLANTED:| PROGRAMMER: MODEL 3031A| LEAD: MODEL 3093 |