FDA Adverse Event
Injury
Summary report: N
PENTA
MDR report key: 2800902
·
Received October 18, 2012
Report
- Report Number
- 1627487-2012-06588
- Event Type
- Injury
- Date Received
- October 18, 2012
- Date of Event
- September 24, 2012
- Report Date
- September 24, 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 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 ADEQUATE COVERAGE. AS A RESULT, THE PT'S SCS SYSTEM WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PENTA | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3228 | 3434495 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention | SCS IPG: MODEL 3716| EXPLANT:| IMPLANT: |