FDA Adverse Event
Malfunction
Summary report: N
CHARGING SYSTEM
MDR report key: 3113027
·
Received May 8, 2013
Report
- Report Number
- 1627487-2013-03615
- Event Type
- Malfunction
- Date Received
- May 8, 2013
- Date of Event
- April 17, 2013
- Report Date
- April 17, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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
THE PT REPORTED SHE EXPERIENCED HER CHARGING SYSTEM'S AC LINE CORD SPARKING WHEN PLUGGED INTO ANY ELECTRICAL OUTLET. SUBSEQUENTLY, A REPLACEMENT CHARGING SYSTEM (LOW ENERGY) WAS SENT TO THE PT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202320 | CHARGING SYSTEM | SCS CHARGING SYSTEM | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3721 | 3535049 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention | IMPLANT DATE:| SCS ANCHOR, MODEL 1192 (2)| SCS LEAD, MODEL 3286 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS IPG, MODEL 3788 |