FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 4193312
·
Received October 20, 2014
Report
- Report Number
- 1627487-2014-12694
- Event Type
- Injury
- Date Received
- October 20, 2014
- Date of Event
- April 15, 2014
- Report Date
- September 23, 2014
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AN 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'S LEG WAS AMPUTATED AND HIS PROSTHETIC LEG IS PRESSING ON THE IPG SITE AND CAUSING PAIN. SURGICAL INTERVENTION IS PLANNED TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 667132 | EON MINI | SCS IPG | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3716872 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other | SCS LEAD: MODEL 3228| IMPLANT DATE: |