FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2604568
·
Received June 8, 2012
Report
- Report Number
- 3004209178-2012-04218
- Event Type
- Malfunction
- Date Received
- June 8, 2012
- Report Date
- May 12, 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
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
LEAD, MODEL 3889-28, LOT# V141293, IMPLANTED: (B)(6) 2009. (B)(4).
Description of Event or Problem · 1
THE DEVICE WORKED FOR A LITTLE WHILE BUT HAS NOT WORKED FOR APPROXIMATELY 3 YEARS, SO THE PATIENT DOES NOT USE IT. 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 | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |