FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1181374
·
Received September 24, 2008
Report
- Report Number
- 3004209178-2008-06103
- Event Type
- Malfunction
- Date Received
- September 24, 2008
- Date of Event
- January 1, 2007
- Report Date
- August 29, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT FELL DOWN SOME STEPS A YEAR AGO AND MAY HAVE DAMAGED THE DEVICE BY BREAKING OR BENDING IT. PRIOR TO THE FALL THE PT HAD NO THERAPEUTIC BENEFIT FROM HER DEVICE. WHEN SITTING, SHE EXPERIENCED PAIN IN HER VAGINAL AREA AND FELT SURGING AT TIMES. SHE HAD SEVERAL ADJUSTMENTS TO HER PROGRAMMING WITHOUT SUCCESS AND HAD TURNED OFF HER DEVICE. FURTHER INFORMATION 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 | 68 YR | Required Intervention | IMPLANTED:| PROGRAMMER: MODEL 3031A| LEAD: MODEL 3889| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 3095 |