FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2478255
·
Received March 5, 2012
Report
- Report Number
- 3004209178-2012-01361
- Event Type
- Malfunction
- Date Received
- March 5, 2012
- Report Date
- February 29, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: LEAD MODEL # 3889-28 LOT # V071771 IMPLANTED (B)(6) 2008 EXPLANTED UNKNOWN; PROGRAMMER MODEL 3037 LOT # NJD063302N.
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT THE PATIENT'S DEVICE DID NOT WORK ANY LONGER AND PATIENT'S PREVIOUS HEALTH CARE PROFESSIONAL WOULD NOT MANAGE HER DEVICE ANY LONGER. THE PATIENT NO LONGER HAD INSURANCE. IN LATER REPORTING, IT WAS NOTED THAT THE PATIENT WAS LOOKING FOR A NEW HEALTHCARE PROVIDER; SHE LOST HER (B)(6). THE PATIENT WAS EXPERIENCING A SHOCKING OR JOLTING SENSATION WHICH STARTED LAST SUMMER. AT THAT TIME, THE PATIENT TURNED HER STIMULATOR OFF AND HAD NOT TURNED IT BACK ON. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MDT PUERTO RICO OPERATIONS CO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |