FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 1053613
·
Received May 23, 2008
Report
- Report Number
- 3004209178-2008-02759
- Event Type
- Injury
- Date Received
- May 23, 2008
- Report Date
- April 23, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT EXPERIENCED A STAPH INFECTION AND THAT HIS INTERSTIM II DEVICE WAS REMOVED. 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 | Required Intervention | IMPLANTED:| LEAD MODEL 3889 LOT#V012900| EXPLANTED: |