FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 2831675
·
Received November 9, 2012
Report
- Report Number
- 1627487-2012-06730
- Event Type
- Injury
- Date Received
- November 9, 2012
- Date of Event
- October 17, 2012
- Report Date
- October 17, 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 2. REFERENCE MFR. REPORT # 1627487-2012-06731. IT WAS REPORTED THE PT HAD FALLEN. SINCE THE FALL, THE PT HAS BEEN EXPERIENCING DISCOMFORT AT THE NECK AND LEAD SITE. IT WAS ALSO REPORTED THE IPG SHUTS OFF PERIODICALLY. THE PT PLANS TO HAVE THE IPG REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON MINI | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3584294 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention | SCS EXTENSIONS: MODEL 3383 (2)| IMPLANT: |