FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 1171226
·
Received September 22, 2008
Report
- Report Number
- 3004209178-2008-05995
- Event Type
- Injury
- Date Received
- September 22, 2008
- Date of Event
- January 1, 2008
- Report Date
- August 25, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION AND HER DEVICE WAS REMOVED THE SUMMER AFTER IT WAS IMPLANTED. 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. | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LEAD MODEL: UNK LOT# UNK| EXPLANTED| IMPLANTED |