FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 1950377
·
Received December 14, 2010
Report
- Report Number
- 3007566237-2010-10454
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- December 7, 2010
- Report Date
- December 8, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, HIGH IMPEDANCES WERE MEASURED AND THAT THE LEAD WOULD NOT TIGHTEN IN THE NEUROSTIMULATOR. THREE ATTEMPTS OF INSERTING THE LEAD INTO THE DEVICE WITHOUT SUCCESS. THE PHYSICIAN THEN IMPLANTED A NEW NEUROSTIMULATOR AND EVERYTHING "TURNED OUT FINE." THE PT WAS REPORTED AS DOING GREAT WITH NO COMPLICATIONS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MEDTRONIC NEUROMODULATION | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | PROGRAMMER: MODEL 3037, LOT# NJD111627N| LEAD: MODEL 3889-28, LOT# V526889| IMPLANTED:| EXTENSION: MODEL 3093-10, LOT# NAH040451V| EXPLANTED:| EXPLANTED:| IMPLANTED: |