FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 2850132
·
Received November 27, 2012
Report
- Report Number
- 1627487-2012-14088
- Event Type
- Injury
- Date Received
- November 27, 2012
- Date of Event
- November 6, 2012
- Report Date
- November 6, 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 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 PATIENT IS EXPERIENCING DISCOMFORT AT HER IPG SITE. THE PATIENT HAS TRIED CREAMS AND PATCHES WITHOUT SUCCESS. THE PATIENT IS REQUESTING TO HAVE HER IPG RELOCATED. SURGICAL INTERVENTION IS PENDING TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON MINI | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3586559 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention | SCS LEAD, MODEL 3228| IMPLANT DATE: |