FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 1864494
·
Received October 6, 2010
Report
- Report Number
- 3007566237-2010-07637
- Event Type
- Injury
- Date Received
- October 6, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 10, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING EXPLANT OF DEVICE AND LEAD, THE BODY OF THE LEAD SEPARATED JUST PROXIMAL TO THE TINES AND THE LEAD WIRES STRIPPED OUT OF THE DISTAL PORTION OF THE LEAD LEAVING THE ELECTRODE CONTACT RINGS STILL IMPLANTED IN THE PATIENT. PATIENT HAD DEVICE REMOVED PRIOR TO MRI. ADDITIONAL INFORMATION WILL BE REPORTED WHEN IT IS AVAILABLE.
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 | IMPLANTED:| LEAD: MODEL 3093 LOT# UNKNOWN| EXPLANTED: |