FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 2881142
·
Received December 14, 2012
Report
- Report Number
- 1627487-2012-14190
- Event Type
- Injury
- Date Received
- December 14, 2012
- Date of Event
- November 26, 2012
- Report Date
- November 26, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- 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 PT WAS EXPERIENCING DISCOMFORT AT HIS IPG SITE WHILE WALKING AND EXERCISING. THE PT UNDERWENT REVISION SURGERY ON (B)(6) 201,2 WHERE HIS IPG WAS MOVED TO A NEW LOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON MINI | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3720769 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention | SCS LEAD: MODEL 3228| IMPLANT DATE: |