FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1052605
·
Received May 22, 2008
Report
- Report Number
- 3004209178-2008-02758
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Report Date
- April 22, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT WITH AN INTERSTIM DEVICE, WHICH WAS TURNED OFF, WENT THROUGH A SECURITY GATE. AFTER THE SECURITY GATE EXPOSURE, WHEN THE PT TURNS THE DEVICE, ON THE STIMULATION IS IN THE WRONG LOCATION. 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 | EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL 3031A LOT # NGM022189P| EXPLANTED:| IMPLANTED:| EXTENSION MODEL 3095 LOT #NAH020597V |