BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNK

    MDR report key: 3465301 · Received November 12, 2013

    Report

    Report Number
    1644487-2013-03465
    Event Type
    Malfunction
    Date Received
    November 12, 2013
    Date of Event
    May 10, 2000
    Report Date
    October 14, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    REVIEW OF IN HOUSE PROGRAMMING HISTORY SHOWED HIGH LEAD IMPEDANCE ON A LEAD TEST (LIMIT/HIGH/7) WAS FOUND ON (B)(6) 2000 BUT ABOUT 45 MINUTES LATER, A SUBSEQUENT LEAD TEST RESULTED IN OK RESULTS (OK/OK/0/NO). ON (B)(6) 2004, LEAD DIAGNOSTICS WERE STILL WITHIN NORMAL LIMITS AT OK/OK/0/NO. IT APPEARS LIKELY THAT (B)(^) 2000 WAS THE DATE OF IMPLANT AND INTRAOPERATIVE TROUBLESHOOTING WAS PERFORMED. HOWEVER, THIS GENERATOR IS NOT AVAILABLE IN QAD AND THERE IS NO IT IS UNKNOWN IF THE HIGH IMPEDANCE WAS ONLY PRESENT AT TIME OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585238 LEAD MODEL UNK LEAD LYJ CYBERONICS INC NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Unknown