BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2961920 · Received February 14, 2013

    Report

    Report Number
    1644487-2013-00403
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    April 30, 2012
    Report Date
    January 23, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    THE PATIENT'S EXPLANTED LEAD WAS NOT RETURNED FOR ANALYSIS. THEIR EXPLANTED GENERATOR WAS RETURNED. THEIR GENERATOR BATTERY WAS AT END OF BATTERY LIFE AND DETERMINED TO BE THE RESULT OF NORMAL EXPECTED BATTERY DEPLETION, BASED ON THE BATTERY LIFE ANALYSIS AND ELECTRICAL TEST RESULTS. THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    A HOSPITAL CALLED AND REPORTED THAT THEY HAD A EXPLANTED GENERATOR WHICH WAS REPLACED WITH M103 ON (B)(6) 2013 DUE TO A CARDIAC ARREST IN (B)(6) 2012 AND THE PATIENT WAS RESUSCITATED. THE PATIENT HAD THEIR GENERATOR REPLACED PROPHYLACTICALLY IN CASE IT WAS DAMAGED. THEIR ARREST WAS NOT VNS RELATED. DURING THEIR GENERATOR REPLACEMENT SURGERY IT WAS NOTED THAT THE PATIENT HAD HIGH LEAD IMPEDANCE OVER 10,000OHMS. THE SURGEON TOOK THE NEW GENERATOR OFF THE LEAD AND DID GENERATOR DIAGNOSTICS AND IT WAS ALL OK. THE PATIENT REPORTED THAT HIS GENERATOR WAS WORKING UNTIL ABOUT (B)(6) OF LAST YEAR AND THEN IT QUIT WORKING MEANING THE BATTERY WAS DEAD BUT HE WAS NOT ABLE TO REPLACE IT BECAUSE HE HAD A CARDIAC ARREST AND HAD TO BE DEFIBRILLATED AND THEN HAD TO RECOVER BEFORE HE COULD HAVE HIS GENERATOR REPLACED. THE PIN WAS REINSERTED INTO THE NEW GENERATOR AND IF IT WAS PAST THE CONNECTOR BLOCK. THE SURGEON RAN DIAGNOSTICS AND IT WAS STILL HIGH IMPEDANCE. THEIR GENERATOR WAS NOT INTERROGATED PRIOR TO EXPLANT TO CONFIRM BATTERY STATUS. THEIR LEAD WAS NOT REPLACED AT THIS TIME ON (B)(6) 2013. THE PATIENT WENT IN FOR LEAD REVISION SURGERY ON (B)(6) 2013. AT THIS TIME THEIR EXPLANTED LEAD HAS NOT BEEN RETURNED FOR ANALYSIS AFTER GOOD FAITH ATTEMPTS HAVE BEEN MADE. IT IS NOT KNOWN IF COMPRESSIONS WERE PERFORMED DURING THE PATIENT'S CARDIAC ARREST. THE DEFIBRILLATOR WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65434 LEAD MODEL 302 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 009157

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR