FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 2378579
·
Received December 16, 2011
Report
- Report Number
- 3004209178-2011-09851
- Event Type
- Malfunction
- Date Received
- December 16, 2011
- Date of Event
- January 1, 2009
- Report Date
- October 12, 2007
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- EZW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
LEAD MODEL 3889-28, LOT #V008904, IMPLANTED: (B)(6) 2006, EXPLANTED: NA; EXTENSION MODEL 3095-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: NA; PROGRAMMER MODEL 3031A, SERIAL # (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ELECTRIC SHOCK SENSATION (NOTED AS A 'ZING') ON THE LEFT VAGINAL SIDE WHEN CHANGING POSITION. THE LEADS WERE THEN REPROGRAMMED. THE OUTCOME OF THE EVENT WAS REPORTED AS NOT SERIOUS. 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 | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MDT PUERTO RICO OPERATIONS CO | 3023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |