FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3254809
·
Received July 30, 2013
Report
- Report Number
- 3004209178-2013-12501
- Event Type
- Malfunction
- Date Received
- July 30, 2013
- Report Date
- July 8, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 093-28 LOT# V940070, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT SINCE IMPLANT, THE PATIENT HAD BEEN SHOCKED IN THE VAGINAL AREA AND IT WAS PAINFUL. IT WAS NOTED THAT THE PATIENT WENT FROM AN AMPLITUDE OF 2.0 ALL THE WAY UP TO 8, WHERE SHE COULD NOT STAND THE SHOCKING SENSATION ANYMORE. IT WAS NOTED THAT THE INSURANCE COMPANY TOLD THE PATIENT TO TURN OFF HER THERAPY IN (B)(6) 2012 AND THE INSURANCE COMPANY WANTED THE DEVICE REMOVED. NO REMOVAL WAS CURRENTLY SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 355302 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00053 YR |