FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 2903000
·
Received December 26, 2012
Report
- Report Number
- 1627487-2012-16004
- Event Type
- Injury
- Date Received
- December 26, 2012
- Date of Event
- November 30, 2012
- Report Date
- November 30, 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 THE PT WENT TO THE EMERGENCY ROOM DUE TO BELIEVING HE HAD AN INFECTION AT THE IPG SITE. WHILE IN THE EMERGENCY ROOM, THE PT'S STAPLES WERE REMOVED. THE PT UNDERWENT A F/U VISIT WITH HIS DOCTOR AND NO INFECTION WAS FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON MINI | SCS IPG | LGW | ST JUDE MEDICAL - NEUROMODULATION | 3788 | 3798896 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Hospitalization| R | SCS LEAD: MODEL 3214| IMPLANT: |