FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 2892371
·
Received December 27, 2012
Report
- Report Number
- 1627487-2012-03930
- Event Type
- Injury
- Date Received
- December 27, 2012
- Date of Event
- July 24, 2012
- Report Date
- November 29, 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 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 SINCE IMPLANTATION THE PT HAD BEEN EXPERIENCING PAIN AT HER SCS IPG POCKET SITE. F/U IDENTIFIED THE PT'S POCKET SITE WAS REVISED ON (B)(6) 2012 AND IS BEING MONITORED FOR RESOLUTION OF THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON MINI | SCS IPG | LGW | ST JUDE MEDICAL - NEUROMODULATION | 3788 | 3731888 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention | SCS LEAD: MODEL 3214| IMPLANT DATE: |