FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 3003818
·
Received March 14, 2013
Report
- Report Number
- 3004209178-2013-03692
- Event Type
- Malfunction
- Date Received
- March 14, 2013
- Report Date
- February 27, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3889-28, LOT# V780818, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THEY WERE NOT ABLE TO ADJUST STIMULATION. DISPLAY SHOWED "CALL YOUR DOCTOR" ICON WITH A POR CONDITION, WARNING SCREEN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 107196 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MDT PUERTO RICO OPERATIONS CO | 3023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |