FDA Adverse Event
Malfunction
Summary report: N
CHARGING SYSTEM
MDR report key: 3151486
·
Received June 4, 2013
Report
- Report Number
- 1627487-2013-15757
- Event Type
- Malfunction
- Date Received
- June 4, 2013
- Date of Event
- May 14, 2013
- Report Date
- May 14, 2013
- 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
Description of Event or Problem · 1
THE PT REPORTED THAT HER CHARGING SYSTEM GETS HOT WHILE IN USE. THE PT INDICATED SHE IS NOT EXPERIENCING ANY HEATING AT THE IPG SITE, RATHER THE CHARGING SYSTEM ITSELF BECOMES HOT TO THE TOUCH. THE PT WAS SENT A REPLACEMENT CHARGING SYSTEM. F/U IDENTIFIED THE PT'S ISSUE WAS RESOLVED WITH THE USE OF THE REPLACEMENT CHARGING SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 246406 | CHARGING SYSTEM | SCS CHARGING SYSTEM | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3711 | 3846620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3716| SCS LEAD: MODEL 3228 |