BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2944866 · Received February 5, 2013

    Report

    Report Number
    1644487-2013-00290
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 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
    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

    THE PATIENT'S IMPLANT CARD WAS RECEIVED WHICH INDICATED THAT THE LEAD WAS REPLACED DUE TO A LEAD DISCONTINUITY. HOWEVER, LEAD IMPEDANCE WAS MARKED "OK" ON THE CARD. THE EXPLANTED DEVICES WERE DISCARDED. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION; HOWEVER, THEY HAVE BEEN UNSUCCESSFUL. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    ON (B)(4) 2013, IT WAS REPORTED THAT THE PATIENT WOULD BE SCHEDULED FOR SURGERY DUE TO HIGH IMPEDANCE. THE PATIENT HAD THIS LEAD REVISION SURGERY ALONG WITH A PROPHYLACTIC GENERATOR REPLACEMENT ON (B)(6) 2013. ATTEMPTS ARE BEING MADE FOR ADDITIONAL INFORMATION AND PRODUCT RETURN. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47956 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1257

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR