FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 1972419
·
Received January 24, 2011
Report
- Report Number
- 3007566237-2011-00555
- Event Type
- Injury
- Date Received
- January 24, 2011
- Date of Event
- December 22, 2010
- Report Date
- January 14, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- 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
THE PATIENT EXPERIENCED A SHOCKING/JOLTING SENSATION DOWN TO HER VAGINAL AREA FOLLOWING A REVISION OF THE NEUROSTIMULATOR POCKET TO MAKE IT BIGGER. IMPEDANCE MEASUREMENTS WERE IN NORMAL RANGE. THE PT STILL FELT SHOCKING EVEN WHEN THE AMPLITUDE WAS DECREASED. THE SHOCKING WAS ALSO FELT WHEN THE DEVICE WAS PRESSED ON. 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 | Required Intervention | EXPLANTED:| LEAD: MODEL LEAD URO, LOT# UNK| IMPLANTED: |