FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 2930335
·
Received January 21, 2013
Report
- Report Number
- 1627487-2013-05118
- Event Type
- Injury
- Date Received
- January 21, 2013
- Date of Event
- December 20, 2012
- Report Date
- December 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 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 HAS BEEN EXPERIENCING ITCHING, REDNESS, AND BUMPS AT THE IPG SITE. STEROIDS WERE USED TO TREAT THE SYMPTOMS BUT WERE UNSUCCESSFUL. THE PATIENT UNDERWENT AN ALLERGY TEST BUT THE RESULTS ARE UNKNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28700 | EON MINI | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3818687 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Required Intervention | SCS ANCHORS, MODEL: 1194 (X2)| SCS LEAD, MODEL: 3186 (X2)| IMPLANT:| IMPLANT: |