FDA Adverse Event
Malfunction
Summary report: N
PENTA
MDR report key: 2900771
·
Received December 12, 2012
Report
- Report Number
- 1627487-2012-12775
- Event Type
- Malfunction
- Date Received
- December 12, 2012
- Date of Event
- November 20, 2012
- Report Date
- November 20, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- 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 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 EXPERIENCED A CHANGE IN STIMULATION FOLLOWING A FALL. REPORTEDLY THE PATIENT DOES NOT WANT TO HAVE SURGICAL INTERVENTION TO ADDRESS THE ISSUE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PENTA | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3228 | 3593619 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention | IMPLANT DATE:| SCS IPG, MODEL 3788 |