FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 2850078
·
Received November 26, 2012
Report
- Report Number
- 1627487-2012-11702
- Event Type
- Injury
- Date Received
- November 26, 2012
- Date of Event
- August 2, 2012
- Report Date
- October 29, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- 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 IPG WAS SHUTTING DOWN 5-6 TIMES PER MINUTE. THE PATIENT REPORTED THE ISSUE HAD BEEN PRESENT SINCE IMPLANT. THE SJM REPRESENTATIVE MET WITH THE PATIENT FOR REPROGRAMMING, AND TURNED THE MAGNET MODE OFF. IT WAS REPORTED AN ATTEMPT TO PROVIDE A CYCLING PROGRAM WAS UNSUCCESSFUL TO STOP THE ISSUE. FOLLOW UP IDENTIFIED THE PHYSICIAN REPLACED THE IPG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON MINI | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3751473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention | SCS LEAD: MODEL 3228| IMPLANT DATE: |