FDA Adverse Event
Malfunction
Summary report: N
STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
MDR report key: 3230179
·
Received July 16, 2013
Report
- Report Number
- 3007566237-2013-02367
- Event Type
- Malfunction
- Date Received
- July 16, 2013
- Report Date
- June 19, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT HAD A POSITIVE RESULT DURING THE TRAIL UNTIL SHE PULLED ONE OF THE LEADS OUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329779 | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | NEU_ENS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00070 YR |