FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 2852249
·
Received November 27, 2012
Report
- Report Number
- 1627487-2012-14101
- Event Type
- Injury
- Date Received
- November 27, 2012
- Date of Event
- November 8, 2012
- Report Date
- November 8, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- 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 PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
DEVICE 1 OF 3. REFERENCE MFR REPORT: 1627487-2012-14102, 14103. IT WAS REPORTED THE PT WAS NO LONGER RECEIVING EFFECTIVE STIMULATION. AN SJM REP MET WITH THE PT AND REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. THE PT'S ENTIRE SCS SYSTEM WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON MINI | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3615912 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention | SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE: |