FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2588748
·
Received May 25, 2012
Report
- Report Number
- 3004209178-2012-03731
- Event Type
- Malfunction
- Date Received
- May 25, 2012
- Report Date
- April 28, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
(B)(4). LEAD: MODEL 3889-28, LOT# V933650, IMPLANTED: (B)(6) 2012, EXPLANTED: NA.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT COULD NOT FEEL STIMULATION AND EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT'S DEVICE WAS C ONFIRMED TO BE TURNED OFF. THE PATIENT TURNED THE DEVICE ON WITH THE PATIENT PROGRAMMER AND SHE WAS THEN FEELING STIMULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |