FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 1083483
·
Received July 29, 2008
Report
- Report Number
- 3004209178-2008-04494
- Event Type
- Injury
- Date Received
- July 29, 2008
- Date of Event
- June 18, 2008
- Report Date
- July 1, 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
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S IPG WAS REPLACED DUE TO THE POSSIBILITY OF IT BEING DEFECTIVE. FURTHER INFO IS BEING REQUESTED FROM THE HCP.
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 | 23 YR | Required Intervention | LEAD MODEL 3093 LOT# V030745| PROGRAMMER MODEL 3037 LOT# NJD042669N| EXPLANTED:| IMPLANTED: |