FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 2930336
·
Received January 21, 2013
Report
- Report Number
- 1627487-2013-05117
- Event Type
- Injury
- Date Received
- January 21, 2013
- Date of Event
- December 27, 2012
- Report Date
- December 27, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Removal / Correction Number
- 1627487-05242011-002-R
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CORRECTION/REMOVAL NUMBER: 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
THE PATIENT HAS AN IPG FOR OFF-LABEL USE. IT WAS REPORTED THE IPG IS MOVING IN THE POCKET AND CAUSING DISCOMFORT DUE TO WEIGHT LOSS. THE PATIENT IS SCHEDULED TO UNDERGO SURGICAL INTERVENTION ON A LATER DATE TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28834 | EON MINI | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3053817 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention | SCS LEADS, MODEL: 3181 (X2)| IMPLANT: |