BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 3770407 · Received April 24, 2014

    Report

    Report Number
    1644487-2014-01102
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    July 17, 2013
    Report Date
    March 26, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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

    CLINIC NOTES DATED (B)(6) 2013 NOTE THAT ONE OF THE LEAD WIRES IS BROKEN. IT WAS NOTED THAT THE PATIENT HAS ALREADY SEEN THE SURGEON REGARDING THIS AND THAT REPLACING THE VNS IS BEING CONSIDERED. IT IS UNKNOWN WHETHER OR NOT ANY PATIENT MANIPULATION OR TRAUMA IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE LEAD BREAK. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAS BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249733 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS INC 300-20 35713C

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR