FDA Adverse Event
Malfunction
Summary report: N
EONC
MDR report key: 2935047
·
Received January 28, 2013
Report
- Report Number
- 1627487-2013-04097
- Event Type
- Malfunction
- Date Received
- January 28, 2013
- Date of Event
- January 7, 2013
- Report Date
- January 7, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 HAD RECEIVED A LOW BATTERY FLAG, AND LATER THE IPG WAS NO LONGER PROVIDING STIMULATION. THE PHYSICIAN HAD SUSPECTED THE IPG HAD REACHED END OF LIFE. THE SYSTEM PARAMETERS WERE UNAVAILABLE, AND THE NEXT COURSE OF ACTION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37900 | EONC | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3688 | 3188866 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention | IMPLANT DATE:| SCS LEAD, MODEL 3181 (2) |