FDA Adverse Event
Malfunction
Summary report: N
EON
MDR report key: 2934126
·
Received January 3, 2013
Report
- Report Number
- 1627487-2013-05028
- Event Type
- Malfunction
- Date Received
- January 3, 2013
- Date of Event
- November 5, 2012
- Report Date
- December 5, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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 CHARGER HAS BEEN UNABLE TO COMMUNICATE SUCCESSFULLY WITH THE IPG. AN SJM REPRESENTATIVE IS SCHEDULED TO MEET WITH THE PATIENT FOR TROUBLESHOOTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3967 | EON | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3716 | 3783190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention | SCS LEAD, MODEL: 3186| IMPLANT: |