FDA Adverse Event
Injury
Summary report: N
UNKNOWN STIMULATOR
MDR report key: 2923909
·
Received January 22, 2013
Report
- Report Number
- 3007566237-2013-00236
- Event Type
- Injury
- Date Received
- January 22, 2013
- Report Date
- January 2, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT WAS INFORMED BY THEIR HEALTH CARE PROVIDER THAT A PATIENT HAD HAD A "FAILURE" WHEN THEY FLEW OF A JET SKI AND HIT THE WATER. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROFESSIONAL REPORTED THEY HAD NO SPECIFICS REGARDING THE PATIENT'S EVENT ALTHOUGH IT WAS NOTED HIGH IMPEDANCES AFTER PHYSICAL EVENTS WOULD HAVE MEANT THE PATIENT WOULD HAVE NEEDED TO GO BACK TO THE OPERATING ROOM. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29102 | UNKNOWN STIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | NEU_INTERSTIM_INS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |