FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 2971080
·
Received February 15, 2013
Report
- Report Number
- 1627487-2013-04191
- Event Type
- Injury
- Date Received
- February 15, 2013
- Date of Event
- January 24, 2013
- Report Date
- January 24, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Removal / Correction Number
- 1627487-07262012-001-C
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. 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
DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-04192. IT WAS REPORTED THE PATIENT HAD EXPERIENCED HEATING WHILE CHARGING THE IPG. THE PATIENT DID NOT HAVE A CHARGING BELT. A REPLACEMENT CHARGING BELT WAS SENT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69949 | EON MINI | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3527446 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention | SCS LEAD: MODEL 3286 (2)| SCS ANCHOR: MODEL 1192 (2)| IMPLANT:| IMPLANT: |