FDA Adverse Event
Malfunction
Summary report: N
EON MINI
MDR report key: 2852198
·
Received November 12, 2012
Report
- Report Number
- 1627487-2012-06737
- Event Type
- Malfunction
- Date Received
- November 12, 2012
- Date of Event
- August 1, 2012
- Report Date
- October 18, 2012
- Manufacturer
- ST. JUDE MEDICA L- NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Removal / Correction Number
- 1627487-05242011-002-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CORRECTION/REMOVAL REPORTING #: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. 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 HAS BEEN UNABLE TO COMMUNICATE WITH THE CHARGER. AS A RESULT, THE PATIENT LOST STIMULATION. THE PATIENT IS SCHEDULED TO MEET WITH AN SJM REPRESENTATIVE TO TROUBLESHOOT THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON MINI | SCS IPG | LGW | ST. JUDE MEDICA L- NEUROMODULATION | 3788 | 2744438 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention | SCS LEAD: MODEL 3186| IMPLANT: |