FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 1082617
·
Received July 25, 2008
Report
- Report Number
- 3004209178-2008-04396
- Event Type
- Injury
- Date Received
- July 25, 2008
- Date of Event
- January 8, 2008
- Report Date
- June 24, 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
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT'S SYSTEM WAS REPLACED DUE TO SHOCKING. NO COMPLICATIONS WERE 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 | 42 YR | Required Intervention | LEAD MODEL 3889 LOT# V009195| EXTENSION MODEL 3095 LOT# NAH033227V| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED: |