BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3012462 · Received March 20, 2013

    Report

    Report Number
    1644487-2013-00734
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    October 1, 2012
    Report Date
    February 19, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    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 WAS SCHEDULED FOR SURGERY DUE TO HIGH LEAD IMPEDANCE. THE DEVICE HISTORY REPORT FOR THE VNS LEAD WAS REVIEWED AND NO NON CONFORMANCES WERE FOUND. NO PATIENT TRAUMA OR DEVICE MANIPULATION WAS REPORTED. ACCORDING TO THE PHYSICIAN THE PATIENT'S VNS OUTPUT WAS LOWERED TO 1.0 MA. THE PHYSICIAN HOWEVER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION. THE EXPLANTED PRODUCTS WERE DISCARDED.

    Description of Event or Problem · 1

    NEW INFORMATION WAS RECEIVED WHICH INDICATES THAT THE VNS GENERATOR AND LEAD WERE REPLACED ON (B)(6) 2013 DUE TO BATTERY DEPLETION, PROPHYLACTIC AND LEAD DISCONTINUITY. THE LEAD IMPEDANCE OF THE NEW IMPLANT IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116629 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200799

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR