FDA Adverse Event
Summary report: N
EON MINI
MDR report key: 3961074
·
Received December 16, 2014
Report
- Report Number
- 1627487-2014-12473
- Date Received
- December 16, 2014
- Date of Event
- June 18, 2014
- Report Date
- June 22, 2015
- Manufacturer
- ST JUDE MEDICALNEUROMODULATION
- 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 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 THAT THE PATIENT'S IPG TURNS ON AND OFF WITHOUT PROMPTING. WHEN THE SYSTEM TURNED BACK ON, THE STIMULATION WAS SHARPER THAN NORMAL. AN SJM REPRESENTATIVE INTERROGATED THE SYSTEM AND CONFIRMED THE ISSUES. SURGICAL INTERVENTION IS PLANNED TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 824521 | EON MINI | SCS IPG | GZB | ST JUDE MEDICALNEUROMODULATION | 3788 | 3888416 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other | SCS ANCHORS: MODEL 1194 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3228, |