FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 6199689
·
Received December 22, 2016
Report
- Report Number
- 3004209178-2016-27077
- Event Type
- Injury
- Date Received
- December 22, 2016
- Date of Event
- September 18, 2013
- Report Date
- December 22, 2016
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- UDI-DI
- 00613994913654
- 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
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED FROM A CONSUMER ((B)(6)) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD WERE REMOVED ON (B)(6) 2016. THEY STOPPED USING THEIR IMPLANT A FEW MONTHS AFTER IT WAS IMPLANTED BECAUSE IT DIDN'T WORK FOR THEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 851205 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 | 00613994913654 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |