FDA Adverse Event
Injury
Summary report: N
MEDTRONIC
MDR report key: 1588691
·
Received January 24, 2010
Report
- Report Number
- MW5014489
- Event Type
- Injury
- Date Received
- January 24, 2010
- Date of Event
- January 21, 2010
- Report Date
- January 23, 2010
- Manufacturer
- MEDTRONIC
- Product Code
- EZW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
HAD INTERSTIM REMOVED 2 DAYS AGO DUE TO SEVERE BACK AND LEFT LEG PAIN. IT IS BELIEVED TO HAVE PUT PRESSURE ON MY SIATICA NERVE. SINCE IT HAS BEEN REMOVED, THERE IS NO MORE PAIN IN MY BACK OR MY LEFT LEG. PEOPLE SHOULD BE MADE AWARE OF THIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC | INTERSTIM | EZW | MEDTRONIC | 3023 STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |