FDA Adverse Event
Malfunction
Summary report: N
EON 16 - CHANNEL IPG
MDR report key: 2260142
·
Received August 25, 2011
Report
- Report Number
- 1627487-2011-04078
- Event Type
- Malfunction
- Date Received
- August 25, 2011
- Date of Event
- July 27, 2011
- Report Date
- July 27, 2011
- 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
THE PATIENT RECEIVED HIS FIRST SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THE PATIENT'S FIRST SYSTEM WAS SHUTTING OFF ON MULTIPLE OCCASIONS WHEN THE PATIENT WAS IN HIS BEDROOM. THE PATIENT REPORTED BEING ABLE TO TURN THE SYSTEM ON AGAIN. THE PATIENT WAS ASKED TO DOCUMENT WHEN THESE EVENTS OCCUR. FOLLOW UP REVEALED THERE WERE NO OTHER REPORTS OF THE ISSUE, AND NO OTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON 16 - CHANNEL IPG | TOTALLY IMPLANTABLE PULSE GENERATOR | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3716 | 2877997 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | SCS LEAD, MODEL 3149 (2)| SCS EXTENSION, MODEL 3343| IMPLANT DATE:| IMPLANT DATE: |