FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 4251419
·
Received November 14, 2014
Report
- Report Number
- 3007566237-2014-03340
- Event Type
- Malfunction
- Date Received
- November 14, 2014
- Report Date
- October 22, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT¿S FIRST IMPLANT, WHICH WAS IMPLANTED IN (B)(6) 2013, FLIPPED BECAUSE SOMEONE KNEED THEM IN THE BACK AND THE LEAD ALSO PULLED OUT. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 736547 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00054 YR |