FDA Adverse Event
Injury
Summary report: N
EONC
MDR report key: 2894939
·
Received December 20, 2012
Report
- Report Number
- 1627487-2012-13247
- Event Type
- Injury
- Date Received
- December 20, 2012
- Date of Event
- November 27, 2012
- Report Date
- November 27, 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 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
IT WAS REPORTED THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE. THE PHYSICIAN PRESCRIBED NEW MEDICATION FOR THE PATIENT. THE PATIENT WAS TO FOLLOW-UP WITH PHYSICIAN AT A LATER DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EONC | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3688 | 3598569 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention | IMPLANT DATE:| SCS ANCHOR, MODEL 1192 (2)| SCS LEAD, MODEL 3186 (2)| IMPLANT DATE: |