FDA Adverse Event
Injury
Summary report: N
PENTA
MDR report key: 2892434
·
Received December 27, 2012
Report
- Report Number
- 1627487-2012-03935
- Event Type
- Injury
- Date Received
- December 27, 2012
- Date of Event
- November 30, 2012
- Report Date
- November 30, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- 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 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
IT WAS REPORTED, THE PT IS NOT RECEIVING EFFECTIVE STIMULATION. SURGICAL INTERVENTION HAS BEEN SCHEDULED TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PENTA | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3228 | 3339584 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention | IMPLANTED:| SCS IPG: MODEL 3788 |