FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 3764578
·
Received April 14, 2014
Report
- Report Number
- 1627487-2014-26308
- Event Type
- Injury
- Date Received
- April 14, 2014
- Date of Event
- March 12, 2014
- Report Date
- March 25, 2014
- Manufacturer
- ST. JUDE MEDICAL ¿ NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- 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 WAS NOT PARALLEL TO THE SKIN SURFACE. SURGICAL INTERVENTION WAS DONE TO REVISE THE IOG POCKET WHICH RESOLVED THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226938 | EON MINI | SCS IPG | GZB | ST. JUDE MEDICAL ¿ NEUROMODULATION | 3788 | 4288794 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other | IMPLANT:| IMPLANT:| SCS LEAD: MODEL 3186 (2)| SCS ANCHOR: MODEL 1192 |