FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 6095055
·
Received November 11, 2016
Report
- Report Number
- 3004209178-2016-23732
- Event Type
- Malfunction
- Date Received
- November 11, 2016
- Report Date
- November 10, 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
- KY, 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
A HEALTHCARE PROVIDER (HCP) REPORTED THAT A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) FLOATS AROUND AND FLIPS AROUND BECAUSE THE POCKET HAD GOTTEN LARGER. THEY WERE HAVING TROUBLE LOCATING THE INS TO TURN IT OFF. THE PATIENT WAS ALSO HAVING AN ELECTRO CAUTERY PROCEDURE AND THE HCP WANTED TO KNOW IF THEY HAD TO TURN THE DEVICE OFF. IT WAS UNCLEAR IF IT WAS RELATED TO THE DEVICE OR THERAPY. IT WAS RECOMMENDED THAT THE PATIENT FOLLOW UP WITH THEIR MANAGING HCP ABOUT THE INS. THE INS WAS INDICATED FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION/GASTROINTESTINAL/PELVIC FLOOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 746127 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 | 00613994913654 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |