BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2980794 · Received February 15, 2013

    Report

    Report Number
    3008642652-2013-00491
    Event Type
    Death
    Date Received
    February 15, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PT DEATH) HAS BEEN INVESTIGATED. UPON RECEIPT, ALL GELS WERE DEPLOYED, THE TRUNK CABLE WAS PULLED FROM THE STRAIN RELIEF, THE J702 CONNECTOR WAS DAMAGED AND THE ELECTRODE BELT FAILED THE DETECT AND TREAT TEST. THE CAUSE FOR THE TEST FAILURE WAS DAMAGE TO J702, THE TRUNK CABLE CONNECTOR INSIDE THE DISTRIBUTION NODE. THE DAMAGE TO THE J702 CONNECTOR WAS DUE TO THE PULLING OF THE TRUNK CABLE FROM THE STRAIN RELIEF. THE ROOT CAUSE FOR THE PULLED TRUNK CABLE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE WHEN ATTEMPTING TO REMOVE THE DEVICE FROM THE PT. THE DEATH MEMO CONCLUDES THAT THE DEVICE PROPERLY DETECTED VENTRICULAR ARRHYTHMIAS. HOWEVER, AT 17:34:27, THE PT WAS IN A SLOW VENTRICULAR TACHYCARDIA AT 107 BPM BELOW THE THRESHOLD FOR TREATMENT. THEREFORE, THE PT WAS NOT TREATED. AT 17:35:40, THE PT WAS IN VENTRICULAR FIBRILLATION, BUT THE DEVICE DID NOT TREAT DUE TO DETECTION OF DUAL NOISE, RIGHT, FRONT, LEFT AND BACK FALLOFF (THE DEVICE WAS PROBABLY BEING REMOVED). THE BELT WAS THEN DISCONNECTED AND SHUTDOWN.

    Description of Event or Problem · 1

    ZOLL CUSTOMER SUPPORT WAS NOTIFIED OF A PT DEATH VIA AN EMAIL FROM ZOLL LOGISTICS. PER ZOLL LOGISTICS, THE PT PASSED AWAY ON (B)(6) 2013 AT THE HOSPITAL. UPON RECEIPT OF ELECTRODE BELT SN (B)(4), THE ELECTRODE BELT FAILED THE DETECT AND TREAT TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69765 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death