BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2030476 · Received March 9, 2011

    Report

    Report Number
    1644487-2011-00439
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 7, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 DEVICE SHOWED HIGH LEAD IMPEDANCE UPON DIAGNOSTIC TESTING. FOLLOW-UP WITH PATIENT'S TREATING NEUROLOGIST REVEALED THAT CHEST AND NECK X-RAYS OF THE PATIENT'S DEVICE WERE TAKEN. THE NECK X-RAYS DID NOT REVEAL ANY OBVIOUS ANOMALIES AND THE LEAD COULD NOT BE VISUALIZED ON THE CHEST X-RAYS DUE TO POOR IMAGE QUALITY. THE X-RAYS WERE NOT SENT TO THE MANUFACTURER FOR REVIEW. NO PATIENT MANIPULATION OR TRAUMA OCCURRED, PER PHYSICIAN. THE PATIENT UNDERWENT FULL REVISION SURGERY AND THE EXPLANTED PRODUCTS WERE RETURNED TO MANUFACTURER, BUT ANALYSIS IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS INC 300-20 1061

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR