FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 6099697
·
Received November 14, 2016
Report
- Report Number
- 3004209178-2016-23895
- Event Type
- Injury
- Date Received
- November 14, 2016
- Date of Event
- July 12, 2016
- Report Date
- November 14, 2016
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- UDI-DI
- 00613994913654
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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
PATIENT REPORTED THAT IMPLANTABLE NEUROSTIMULATOR (INS) WAS STICKING OUT SINCE IMPLANTATION ON (B)(6) 2016. REVISION WAS DONE ON (B)(6) 2016 AND INS WAS PUSHED BACK INTO THE POCKET. PATIENT WAS IMPLANTED FOR GASTROINTESTINAL/ PELVIC FLOOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 750855 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 | 00613994913654 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |