BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 4192728 · Received October 9, 2014

    Report

    Report Number
    3008642652-2014-03206
    Event Type
    Death
    Date Received
    October 9, 2014
    Date of Event
    August 20, 2014
    Report Date
    October 8, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN 07032374 IS COMPLETE. AS RECEIVED, THE MONITOR WAS FULLY FUNCTIONAL AND ABLE TO DETECT AND TREAT. DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) IS COMPLETE. AS RECEIVED, ALL GELS WERE DEPLOYED AND THE ELECTRODE BELT WAS FULLY FUNCTIONAL. THERE IS NO EVIDENCE TO SUGGEST THAT THE LIFEVEST CAUSED OR CONTRIBUTED TO THE DEATH. MONITOR (B)(4): (B)(6) 2012 - REUSE, ELECTRODE BELT (B)(4): (B)(6) 2010 - REUSE.

    Description of Event or Problem · 1

    A UNITED STATES DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PT PASSED AWAY ON (B)(6) 2014 AT THE HOSPITAL. AT 23:39:51 ON (B)(6) 2014, THE LIFEVEST DETECTED ATRIAL FLUTTER AT 40 BPM TRANSITIONING TO ASYSTOLE. THE PT'S RHYTHM CONVERTED TO ASYSTOLE AT 23:41:30. THE PT RECEIVED A TREATMENT DEFIBRILLATION AT 23:42:39 IN RESPONSE TO ASYSTOLE. THE POST SHOCK RHYTHM WAS ASYSTOLE. THE PT RECEIVED A SECOND TREATMENT DEFIBRILLATION AT 23:43:01 IN RESPONSE TO ASYSTOLE. THE POST SHOCK RHYTHM WAS ASYSTOLE. OVERSENSING OF SMALL CARDIAC SIGNAL CONTRIBUTED TO THE FALSE DETECTION. THE RESPONDS BUTTONS WERE PRESSED AFTER THE SECOND TREATMENT OCCURENCE. THE ELECTRODE BELT WAS DISCONNECTED AT 23:43:52. THERE IS NO INDICATION THAT THE DEFIBRILLATIONS CONTRIBUTED TO THE PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636903 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death