FDA Adverse Event
Injury
Summary report: N
EON
MDR report key: 2843396
·
Received November 15, 2012
Report
- Report Number
- 1627487-2012-03706
- Event Type
- Injury
- Date Received
- November 15, 2012
- Date of Event
- September 17, 2012
- Report Date
- October 22, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, 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
THE PT REPORTED EXPERIENCING PAIN AND TENDERNESS AT HER SCS IPG POCKET SITE WITH AND WITHOUT STIMULATION. THE PT IS WORKING WITH HER PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION. FOLLOW-UP IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3716 | 119790 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention | SCS LEAD: MODEL 3186 (2)| IMPLANT DATE: |