FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2428505
·
Received January 26, 2012
Report
- Report Number
- 3004209178-2012-00509
- Event Type
- Malfunction
- Date Received
- January 26, 2012
- Date of Event
- January 24, 2012
- Report Date
- January 24, 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
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
LEAD: MODEL # 3889-28, LOT # V466586, IMPLANTED: 2010 (B)(6), EXPLANTED: UNKNOWN. PROGRAMMER: MODEL # 3037, LOT # NJD107582N.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. CURRENT IMPEDANCE MEASUREMENTS WERE NORMAL, MAYBE A LITTLE HIGHER THAN NORMAL. PATIENT WAS ABLE TO FEEL STIMULATION ON PROGRAM 3 WITH C+, 1- AND 5.6V AS AMPLITUDE. AT 1.5V AND 330US: C0: 1262, C1: 1262, C2: 833, C3: 1063 01: 2459, 02: 1445, 03: 2536, 12: 1282, 13: 2536, 23: 1282 ON SOME PROGRAMS PATIENT FELT IT IN HIP AREA. WITH C+, 1- PATIENT WAS FEELING STIMULATION IN VAGINA AND PHYSICIAN WAS GOING TO LEAVE IT IN THIS PROGRAMMED SETTING TO ASSESS THERAPY. 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 | 75 YR |