FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 2903063
·
Received January 3, 2013
Report
- Report Number
- 1627487-2013-15006
- Event Type
- Injury
- Date Received
- January 3, 2013
- Date of Event
- December 6, 2012
- Report Date
- December 6, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Removal / Correction Number
- 1627487-05242011-002-R
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2053 | EON MINI | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 2849290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention | IMPLANT DATE: | IMPLANT DATE: | IMPLANT DATE: | SCS EXTENSION: MODEL 3383 (2)| SCS LEAD: MODEL 3186| SCS LEAD: MODEL 3219 |