FDA Adverse Event
Malfunction
Summary report: N
EON MINI
MDR report key: 4142579
·
Received September 26, 2014
Report
- Report Number
- 1627487-2014-05687
- Event Type
- Malfunction
- Date Received
- September 26, 2014
- Date of Event
- April 1, 2014
- Report Date
- September 4, 2014
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- 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 HAS BEEN WITHOUT STIMULATION DUE TO THE IPG BEING UNABLE TO COMMUNICATE WITH THE CHARGER. A REPLACEMENT CHARGER WAS SENT TO THE PATIENT TO PROVIDE RESOLUTION BUT WAS UNSUCCESSFUL. AS A RESULT, THE PATIENT MAY UNDERGO SURGICAL INTERVENTION ON A LATER DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 600562 | EON MINI | SCS IPG | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3535759 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | SCS ANCHOR, MODEL: 1192| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD, MODEL: 3228 |