FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 1936194
·
Received December 14, 2010
Report
- Report Number
- 3007566237-2010-10457
- Event Type
- Injury
- Date Received
- December 14, 2010
- Date of Event
- December 1, 2010
- Report Date
- December 6, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD BOTH THEIR NEUROSTIMULATORS AND LEADS (PT HAD BILATERAL IMPLANTS) EXPLANTED DUE TO CONTINUED PAIN DESPITE REPROGRAMMING EFFORTS. ADDITIONAL INFO WAS REQUESTED. SEE MANUFACTURER REPORT 3007566237201010458.
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 | LEAD: MODEL LEAD URO, LOT# UNKNOWN| IMPLANTED:| EXPLANTED: |