FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 1220426
·
Received October 31, 2008
Report
- Report Number
- 3004209178-2008-07104
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 2, 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
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED A LACK OF THERAPEUTIC EFFECT. THE STRESS OF FAMILY EVENTS, WHICH HAVE OCCURRED IN THE PAST TWO DAYS, HAVE CHANGED HER THERAPY'S EFFECTIVENESS. WHEN SHE WAS UNDER STRESSFUL SITUATIONS SHE WOULD WET HERSELF. FURTHER INFORMATION 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 | 70 YR | EXPLANTED:| LEAD: MODEL 3889| IMPLANTED:| PROGRAMMER: MODEL 3037 |