BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD 302

    MDR report key: 933527 · Received April 10, 2007

    Report

    Report Number
    1644487-2007-00092
    Event Type
    Malfunction
    Date Received
    April 10, 2007
    Date of Event
    March 15, 2007
    Report Date
    March 15, 2007
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    p970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE DID NOT CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 1

    PT UNDERWENT REVISION SURGERY TO HAVE THE GENERATOR AND LEAD REMOVED SO THAT PT COULD UNDERGO AN MRI. THE LEAD AND GENERATOR WERE EXPLANTED AND RETURNED TO CYBERONICS, INC. FOR PRODUCT ANALYSIS. THERE WAS NO ALLEGATION AGAINST THE DEVICE AT THE TIME OF EXPLANT. A LEAD DISCONTINUITY WAS DISCOVERED DURING PRODUCT ANALYSIS AT CYBERONICS INC. DUE TO METAL DISSOLUTION, THE FRACTURE MECHANISM CANNOT BE ASCERTAINED. IT IS UNK AT THIS TIME IF PT WILL BE REIMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD 302 LYJ LYJ CYBERONICS, INC. 302-20 7763

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR