FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3770598
·
Received April 24, 2014
Report
- Report Number
- 3007566237-2014-01135
- Event Type
- Injury
- Date Received
- April 24, 2014
- Report Date
- April 3, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE DEVICE WAS CHANGED BECAUSE THE PATIENT WAS GETTING SHOCKED. IT WAS STATED A ¿METAL PIECE¿ WAS LEFT IN THE PATIENT. THE DOCTOR REPORTEDLY REMOVED EVERYTHING, EXCEPT THE ¿METAL PIECE, BUT PUT IT IN ANOTHER PLACE.¿ IT WAS UNKNOWN IF THIS WAS IN REFERENCE TO THE LEAD OR ACTUAL DEVICE. IT WAS STATED THE LEAD WAS REMOVED. IT WAS THOUGHT THAT THIS OCCURRED IN (B)(6) 2010. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250186 | IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |