FDA Adverse Event
Malfunction
Summary report: N
EON MINI
MDR report key: 3042476
·
Received April 4, 2013
Report
- Report Number
- 1627487-2013-05469
- Event Type
- Malfunction
- Date Received
- April 4, 2013
- Date of Event
- March 12, 2013
- Report Date
- March 12, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- 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'S IPG BECAME NON-FUNCTIONAL AFTER THE PATIENT WAS IN A CAR ACCIDENT. IT WAS ALSO REPORTED THE CHARGER AND PROGRAMMER CAN NO LONGER COMMUNICATE WITH THE IPG. THE PATIENT WILL UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 138932 | EON MINI | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3531723 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | IMPLANT:| SCS LEAD: MODEL 3228 |