FDA Adverse Event
Injury
Summary report: N
MEDTRONIC
MDR report key: 1210924
·
Received October 23, 2008
Report
- Report Number
- MW5008740
- Event Type
- Injury
- Date Received
- October 23, 2008
- Date of Event
- October 8, 2008
- Report Date
- October 23, 2008
- Manufacturer
- MEDTRONIC
- Product Code
- LGW
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I HAVE A NEUROSTIMULATOR IMPLANTED IN MY RIGHT HIP. THIS WAS PUT IN FOR THE STARTSTIM RESEARCH BEING CONDUCTED IN 2004. THE RESEARCH HAS ENDED. THIS WAS PUT IN TO HELP STIMULATE CHEST PAIN. AT THE TIME I HAD CHRONIC ANGINA. MY PROBLEM IS THIS STIMULATOR ACCORDING TO MY DR. HAS FALLEN AND IS CAUSING ME TO HAVE SEVERE PAIN FROM A SCIATIC NERVE. THIS CAUSES MY WHOLE RIGHT LEG SEVERE PAIN/NUMBNESS. HE RECOMMENDS THAT THE DEVICE BE REMOVED. I HAVE NOT USED THE DEVICE IN OVER 2 YEARS. DATES OF USE: 2004 TO 2008. DIAGNOSIS OR REASON FOR USE: CHRONIC ANGINA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC | NEUROSTIMULATOR | LGW | MEDTRONIC | 7425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |