FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 2792028
·
Received October 12, 2012
Report
- Report Number
- 1627487-2012-03530
- Event Type
- Injury
- Date Received
- October 12, 2012
- Date of Event
- April 19, 2012
- Report Date
- September 18, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- 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 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
IT WAS REPORTED, THE PT IS RECEIVING EFFECTIVE STIMULATION; HOWEVER, SHE IS EXPERIENCING PAINFUL "PULLING" SENSATIONS AT HER SCS IPG POCKET SITE WHEN SHE USES HER SCS SYSTEM STIMULATION. THE PT IS WORKING WITH THE PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON MINI | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3664756 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention | SCS LEAD: MODEL 3228| IMPLANT: |