FDA Adverse Event
Injury
Summary report: N
PENTA
MDR report key: 3052824
·
Received April 2, 2013
Report
- Report Number
- 1627487-2013-12426
- Event Type
- Injury
- Date Received
- April 2, 2013
- Date of Event
- December 8, 2012
- Report Date
- March 8, 2013
- 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 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 PT HAS GRADUALLY LOST STIMULATION COVERAGE OVER THE LAST THREE MONTHS. DIAGNOSTICS REVEALED NUMEROUS ELECTRODES WERE INVALID. THE SJM REP WAS ABLE TO REGAIN 80% COVERAGE. X-RAYS REVEALED NO VISIBLE ANOMALIES. NEXT COURSE OF ACTION IS UNDETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 135472 | PENTA | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3228 | 2879411 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention | SCS IPG, MODEL 3788| IMPLANT DATE: |