FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1133622
·
Received August 20, 2008
Report
- Report Number
- 3004209178-2008-05107
- Event Type
- Malfunction
- Date Received
- August 20, 2008
- Date of Event
- July 21, 2008
- Report Date
- July 21, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IPG REPLACEMENT, AN IMPEDANCE TEST WAS RAN BEFORE CLOSING THE PATIENT'S INCISION. THE IPG SHOWED LOW BATTERY LIFE. THE PHYSICIAN TRIED LOADING PROGRAMS AND IT STILL CAME BACK WITH LOW BATTERY. A NEW IPG WAS OPENED AND USED. THE PATIENT RECOVERED WITHOUT SEQUELAE.
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 | 76 YR | IMPLANTED:| PROGRAMMER MODEL 3031A LOT# NGM012676P| EXPLANTED:| EXTENSION MODEL 3095 LOT# NAH013185V| LEAD MODEL 3889 LOT# J0417616V| IMPLANTED:| EXPLANTED: |