FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 2201805
·
Received August 5, 2011
Report
- Report Number
- 3007566237-2011-06095
- Event Type
- Injury
- Date Received
- August 5, 2011
- Report Date
- July 12, 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). THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEADS", EDUCATIONAL BRIEF/PHYSICIAN COMMUNICATION (DECEMBER 2010).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT NEEDED TO HAVE AN MRI AND ELECTED TO HAVE THE LEAD REMOVED IN ORDER TO PROCEED WITH THE MRI. DURING THE EXPLANT PROCEDURE, THE LEAD BROKE OFF WHILE BEING REMOVED. HALF OF THE LEAD WITH THE ELECTRODES REMAINED IN THE PATIENT. THE PATIENT WAS "FINE" BUT WAS ADVISED NOT TO HAVE MRIS DUE TO THE FRAGMENT REMAINING IN HER BODY.
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# UNKNOWN| IMPLANTED |