BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2101705 · Received May 11, 2011

    Report

    Report Number
    1644487-2011-01066
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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 THE PATIENT'S VNS INDICATED HIGH IMPEDANCE AT AN OFFICE VISIT WHERE THE PATIENT INDICATED IT FELT LIKE HE HAD A BUMP IN HIS NECK FROM THE VNS LEAD. THE PHYSICIAN INDICATED THAT HE COULD NOT SEE ANYTHING WRONG AT THE ELECTRODE SITE. NO TRAUMA OR MANIPULATION WAS REPORTED AND PATIENT IS NOT EXPERIENCING ANY ADVERSE EVENTS. ATTEMPTS FOR FURTHER INFORMATION ARE IN PROGRESS. SURGERY TO REPLACE THE PATIENT'S VNS LEAD AND GENERATOR IS LIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 16913C

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR