FDA Adverse Event
Injury
Summary report: N
PENTA
MDR report key: 2894893
·
Received December 20, 2012
Report
- Report Number
- 1627487-2012-03911
- Event Type
- Injury
- Date Received
- December 20, 2012
- Date of Event
- November 27, 2012
- Report Date
- November 27, 2012
- 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 PATIENT IS EXPERIENCING PAIN AT HIS LEAD INCISION SITE. FOLLOW-UP IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PENTA | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3228 | 3456503 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention | SCS IPG: MODEL 3788| IMPLANT: |