FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 2874234
·
Received December 14, 2012
Report
- Report Number
- 6000032-2012-00225
- Event Type
- Malfunction
- Date Received
- December 14, 2012
- Report Date
- November 27, 2012
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3889-28, LOT # J0337644V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD, PRODUCT ID 3095-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT EXPERIENCED NO STIMULATION. IT WAS STATED THAT THE PATIENT'S DEVICE TURNED OFF. THE PATIENT WAS IMPLANTED IN 2003. NO FURTHER INFORMATION WAS PROVIDED. FURTHER INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MDT SOFAMOR DANEK PUERTO RICO MFG | 3023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |