FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 4112654
·
Received September 10, 2014
Report
- Report Number
- 1627487-2014-08268
- Event Type
- Injury
- Date Received
- September 10, 2014
- Date of Event
- August 16, 2014
- Report Date
- August 20, 2014
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, 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 SCS IPG WILL NO LONGER COMMUNICATE WITH EXTERNAL DEVICES. A REPLACEMENT CHARGER WAS SHIPPED TO THE PATIENT BUT WAS UNABLE TO ESTABLISH COMMUNICATION AS WELL. THE PATIENT HAS LOST SCS SYSTEM STIMULATION. THE PATIENT WILL CONSULT WITH HIS PHYSICIAN REGARDING POSSIBLE SURGICAL INTERVENTION AND NEXT STEPS TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 559084 | EON MINI | SCS IPG | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3740416 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | IMPLANT DATE:| SCS LEAD, MODEL: 3186| IMPLANT DATE:| SCS ANCHOR, MODEL: 1192 |