FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL UNKNOWN
MDR report key: 1052083
·
Received May 20, 2008
Report
- Report Number
- 1644487-2008-01182
- Event Type
- Malfunction
- Date Received
- May 20, 2008
- Date of Event
- January 1, 2008
- Report Date
- April 29, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DIAGNOSTIC TESTING RESULTED IN HIGH LEAD IMPEDANCE. F/U WITH THE SITE REVEALED THAT VNS WAS TURNED OFF FOR A MINOR OPERATION, AND WHEN PROGRAMMED BACK ON, HIGH LEAD IMPEDANCE WAS OBSERVED. THE SITE REPORTED NO FINDINGS ON THE X-RAYS, BUT THE X-RAYS WERE NOT MADE AVAILABLE FOR CYBERONICS TO REVIEW. LEAD REVISION SURGERY WAS PERFORMED. THE EXPLANTED LEAD WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL UNKNOWN | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |