FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2030891
·
Received March 4, 2011
Report
- Report Number
- 3007566237-2011-01630
- Event Type
- Malfunction
- Date Received
- March 4, 2011
- Date of Event
- February 17, 2011
- Report Date
- February 17, 2011
- 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
HIGH IMPEDANCE MEASUREMENTS (>4000 OHMS) WERE SEEN ON SOME OF THE BIPOLAR AND UNIPOLAR ELECTRODE PAIRS. IF ADDITIONAL INFO IS RECEIVED, A F/U REPORT WILL BE SENT.
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 |