BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 1952051 · Received January 4, 2011

    Report

    Report Number
    1644487-2011-02958
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Report Date
    December 6, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INFO IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    A VNS TREATING PHYSICIAN IN (B)(6) REPORTED THAT THEY HAD A PT THAT HAD UNDERGONE A RIGHT SIDED VNS IMPLANTATION AFTER A LEFT SIDED LEAD BREAK. GOOD FAITH ATTEMPTS ARE UNDERWAY FOR FURTHER DETAILS ABOUT THE REPORTED EVENT.

    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