FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 4546712
·
Received February 25, 2015
Report
- Report Number
- 3004209178-2015-03659
- Event Type
- Malfunction
- Date Received
- February 25, 2015
- Date of Event
- February 5, 2015
- Report Date
- February 6, 2015
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# V244043, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT STARTED SEEING A POWER ON RESET CONDITION AND ¿CALL YOUR DOCTOR¿ ICON THE DAY PRIOR TO THE CALL. THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. FOLLOW-UP IS BEING CONDUCTED TO DETERMINE PATIENT SYMPTOMS, OUTCOME, AND ACTIONS TAKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 131589 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR |