FDA Adverse Event
Injury
Summary report: N
PENTA
MDR report key: 2940672
·
Received January 30, 2013
Report
- Report Number
- 1627487-2013-13130
- Event Type
- Injury
- Date Received
- January 30, 2013
- Date of Event
- January 11, 2013
- Report Date
- January 11, 2013
- 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 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 WAS NOT RECEIVING EFFECTIVE STIMULATION. AN SJM REPRESENTATIVE WAS UNABLE TO RESOLVE THE ISSUE WITH REPROGRAMMING. X-RAYS SHOWED NO VISIBLE LEAD MIGRATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 40286 | PENTA | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3228 | 3707791 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention | IMPLANT DATE:| SCS IPG: MODEL: 3688 |