FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 4092076
·
Received September 3, 2014
Report
- Report Number
- 1627487-2014-08238
- Event Type
- Injury
- Date Received
- September 3, 2014
- Date of Event
- August 11, 2014
- Report Date
- August 11, 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
- 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 PATIENT'S SCS IPG WAS NOT CHARGED FOR OVER A YEAR AND WOULD NO LONGER COMMUNICATE WITH EXTERNAL DEVICES. THE PATIENT'S IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2014. THE PATIENT IS REPORTEDLY RECEIVING EFFECTIVE STIMULATION POSTOPERATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535366 | EON MINI | SCS IPG, GZB | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3975682 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other | SCS EXTENSION, MODEL 3383| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD, MODEL 3143 |