FDA Adverse Event
Injury
Summary report: N
UNKNOWN INTERSTIM NEUROSTIMULATOR
MDR report key: 2775945
·
Received October 8, 2012
Report
- Report Number
- 3007566237-2012-02409
- Event Type
- Injury
- Date Received
- October 8, 2012
- Report Date
- September 10, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3095, PRODUCT TYPE EXTENSION PRODUCT ID 3093-28, LOT# V952224, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4). ANALYSIS OF THE LEAD MODEL 3093-28, LOT V952224, FOUND NO SIGNIFICANT ANOMALY. THE BODY WAS CUT THROUGH AND THE PRODUCT SEGMENTED. CONTINUITY WAS ACCEPTABLE ON BOTH SEGMENTS, THOUGH ELECTRODE #1 WAS CRUSHED. ANALYSIS OF THE EXTENSION MODEL 3095 SERIAL UNKNOWN FOUND NO SIGNIFICANT ANOMALY. THE BODY WAS CUT THROUGH AND THE PRODUCT SEGMENTED. CONTINUITY WAS ACCEPTABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD FAILED. THE LEAD AND EXTENSION WERE REMOVED AND NOT REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN INTERSTIM NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | NEU_INTERSTIM_INS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |