FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 1203222
·
Received October 17, 2008
Report
- Report Number
- 3004209178-2008-06683
- Event Type
- Malfunction
- Date Received
- October 17, 2008
- Report Date
- September 18, 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
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED CURLING OF THE LEFT TOES BEFORE SHE WENT THROUGH A SECURITY GATE. AFTER THE EXPOSURE TO THE SECURITY GATE, SHE STILL EXPERIENCED CURLING OF THE LEFT TOES BUT ALSO TINGLING OF THE LEFT LEG, SWELLING OF THE LEFT FOOT AND TENDERNESS AT THE NEUROSTIMULATOR SITE. THE PATIENT WAS AT HOME. 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 | IMPLANTED:| EXPLANTED:| LEAD: MODEL 3889 |