FDA Adverse Event
Malfunction
Summary report: N
EON MINI
MDR report key: 2934285
·
Received January 7, 2013
Report
- Report Number
- 1627487-2013-03040
- Event Type
- Malfunction
- Date Received
- January 7, 2013
- Date of Event
- December 13, 2012
- Report Date
- December 13, 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 INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT IS NO LONGER RECEIVING STIMULATION DUE TO BEING UNABLE TO CHARGE HER SCS SYSTEM AFTER NOT CHARGING THE SYSTEM FOR MONTHS. AN SJM REP WAS ABLE TO CONFIRM THE CHARGING AND NO STIMULATION ISSUES BY USING DIFFERENT CHARGING SYSTEMS AND PT PROGRAMMERS. THE PT IS WORKING WITH THE PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8459 | EON MINI | SCS IPG | LGW | ST. JUDE MEDICAL NEUROMODULATION | 3788 | 3540052 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Required Intervention | SCS LEAD: MODEL 3228| IMPLANT DATE: |