FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2597981
·
Received June 4, 2012
Report
- Report Number
- 3004209178-2012-04005
- Event Type
- Malfunction
- Date Received
- June 4, 2012
- Date of Event
- May 4, 2012
- Report Date
- May 5, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- EZW
- PMA / PMN Number
- P080025
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
ADAPTOR: MODEL 37092, LOT# 314220001, IMPLANTED: 2012 (B)(6), EXPLANTED, LEAD: MODEL 3093-28, LOT# V913912, IMPLANTED: 2012 (B)(6), EXPLANTED, PROGRAMMER: MODEL 3037, SERIAL# (B)(4). (B)(4).
Description of Event or Problem · 1
THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND NO STIMULATION SENSATION SINCE YESTERDAY. SHE COULD NOT GO BEYOND 2.0V FOR EACH PROGRAM. SHE WAS AT HOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
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 | 80 YR |