FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1963494
·
Received December 20, 2010
Report
- Report Number
- 3007566237-2010-10607
- Event Type
- Malfunction
- Date Received
- December 20, 2010
- Report Date
- December 14, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD IN THE PATIENT WAS DAMAGED DURING AN EXPLANT PROCEDURE. ADD'L INFO WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MEDTRONIC NEUROMODULATION | IPG URO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| EXPLANTED:| LEAD: MODEL URO, LOT# UNK |