FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3181555
·
Received June 21, 2013
Report
- Report Number
- 3004209178-2013-10679
- Event Type
- Injury
- Date Received
- June 21, 2013
- Report Date
- June 1, 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
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V969906, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
A POWER-ON-RESET (POR) CONDITION WAS REPORTED. A ¿CALL YOUR DOCTOR¿ ICON WAS BEING DISPLAYED ON THE DAY OF THE REPORT SINCE THE PATIENT HAD SURGERY THE WEEK PRIOR TO THE REPORT FOR A PROLAPSE. IT WAS NOTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283569 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |