FDA Adverse Event
Malfunction
Summary report: N
PENTA
MDR report key: 2884973
·
Received December 4, 2012
Report
- Report Number
- 1627487-2012-03800
- Event Type
- Malfunction
- Date Received
- December 4, 2012
- Date of Event
- November 12, 2012
- Report Date
- November 12, 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 IS NOT RECEIVING EFFECTIVE STIMULATION. A SJM REPRESENTATIVE WAS UNABLE TO RESOLVE THE ISSUE WITH REPROGRAMMING. LEAD DIAGNOSTICS SHOWED INVALID IMPEDANCE VALUES FOR THE SCS LEAD. X-RAYS ARE TO BE TAKEN. 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 | 3801684 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Required Intervention | SCS IGP: MODEL 3788| IMPLANT DATE: |