FDA Adverse Event
Injury
Summary report: N
PENTA
MDR report key: 2926386
·
Received January 16, 2013
Report
- Report Number
- 1627487-2013-12077
- Event Type
- Injury
- Date Received
- January 16, 2013
- Date of Event
- December 19, 2012
- Report Date
- December 19, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- 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 NOT LONGER EXPERIENCING STIMULATION IN THE LOWER BACK. THE SJM REPRESENTATIVE REPROGRAMMING WAS UNSUCCESSFUL. THE PATIENT WILL MEET WITH THE SJM REPRESENTATIVE AND PHYSICIAN TO DISCUSS OPTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 24149 | PENTA | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3228 | 3744687 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention | SCS IPG, MODEL 3688| IMPLANT DATE: |