FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 1000046
·
Received February 15, 2008
Report
- Report Number
- 3004209178-2008-00749
- Event Type
- Injury
- Date Received
- February 15, 2008
- Date of Event
- January 22, 2008
- Report Date
- January 18, 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FINAL DEVICE ANALYSIS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE AND/OR WHEN ADD'L INFO IS RECEIVED FROM THE HCP.
Description of Event or Problem · 1
THE MFR'S REP REPORTED, THAT THE PT HAD AN INFECTION OF HER INTERSTIM DEVICE AND THAT THE DEVICE WOULD BE EXPLANTED. THE DEVICE WAS RETURNED TO THE MFR WITH PAPERWORK CONFIRMING THE INFECTION. 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. | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other | EXTENSION MODEL 3095 LOT#NAH036313V| IMPLANTED| LEAD MODEL 3889 LOT V036953| EXPLANTED| EXPLANTED| IMPLANTED |