BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1023673 · Received April 1, 2008

    Report

    Report Number
    1644487-2008-00828
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 12, 2008
    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

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. RESULTS: REVIEW OF X-RAYS BY THE MFR REVEALED A GROSS LEAD DISCONTINUITY. CONCLUSION: DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT AT A ROUTINE OFFICE VISIT SYSTEM AND NORMAL MODE DIAGNOSTIC TESTS SHOWED HIGH LEAD IMPEDANCE. IT WAS REPORTED THAT DIAGNOSTIC TESTS HAD NOT BEEN PERFORMED PREVIOUSLY. THERE WAS NO BELIEVED TRAUMA OR MANIPULATION OF THE DEVICE. X-RAYS WERE REVIEWED BY THE MFR, AND A GROSS LEAD DISCONTINUITY WAS IDENTIFIED JUST BELOW THE TIE-DOWN. IT WAS ALSO NOTED THAT THE STRAIN RELIEF WAS INADEQUATE, THE TIE-DOWN WAS NOT PLACED ACCORDING TO LABELING, AND THE LEAD APPEARED TWISTED NEAR THE GENERATOR SITE. REVISION SURGERY IS LIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1547

    Patients

    Seq Age Sex Outcome Treatment
    1