FDA Adverse Event
Malfunction
Summary report: N
EON MINI
MDR report key: 2900788
·
Received December 12, 2012
Report
- Report Number
- 1627487-2012-11808
- Event Type
- Malfunction
- Date Received
- December 12, 2012
- Date of Event
- March 5, 2012
- Report Date
- November 20, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Removal / Correction Number
- 1627487-12192011-003-R 1
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS IPG SERIAL NUMBER WAS INCLUDING IN A FIELD ADVISORY. 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 PT'S IPG WAS TURNING ON AND OFF BY ITSELF, AND THE PT REPORTED HE COULD PALPATE THE IPG TO MAKE THE ISSUE OCCUR. THE SJM REP MET WITH THE PT FOR REPROGRAMMING TO TURN THE MAGNET MODE OFF. F/U IDENTIFIED THE IPG HAD A FEW INCIDENTS WHERE THE IPG HAD TURNED OFF AFTER REPROGRAMMING. IT WAS REPORTED THE PHYSICIAN HAD ASKED THE PT TO KEEP TRACK OF THE INSTANCES, AND THE ISSUE HAD NOT RECURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON MINI | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3112881 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention | SCS ANCHOR: MODEL 1192 (2)| SCS LEAD: MODEL 3186 (2)| IMPLANT:| IMPLANT: |