FDA Adverse Event
Malfunction
Summary report: N
EONC
MDR report key: 2915333
·
Received December 28, 2012
Report
- Report Number
- 1627487-2012-14303
- Event Type
- Malfunction
- Date Received
- December 28, 2012
- Date of Event
- December 3, 2012
- Report Date
- December 6, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED THE PT IS NO LONGER RECEIVING STIMULATION. UPON COMMUNICATING WITH THE PROGRAMMER, IT WAS DETERMINED HER IPG IS AT "STIM OFF". THE PT IS PENDING FOLLOW UP WITH AN SJM REP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EONC | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3688 | 3439170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention | SCS LEAD: MODEL 3186 (2)| IMPLANT DATE: |