BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 4192700 · Received October 9, 2014

    Report

    Report Number
    3008642652-2014-03205
    Event Type
    Death
    Date Received
    October 9, 2014
    Date of Event
    August 16, 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 (B)(4) 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, THE DN TO REAR TE CABLE WAS PULLED FROM THE STRING RELIEF. THE ROOT CAUSE OF THE PULLED CABLE WAS LIKELY DUE TO EXCESSIVE FORCE WHEN REMOVING THE BELT FROM THE PT. THERE IS NO INDICATION THAT THE PULL CABLE CONTRIBUTED TO THE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE LIFEVEST CAUSED OR CONTRIBUTED TO THE DEATH. MONITOR (B)(4): (B)(6) 2010 - REUSE, ELECTRODE BELT (B)(4): (B)(6) 2013 - 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 HOME. BETWEEN 10:23:35 AND 10:42:02 ON (B)(6) 2014, THE LIFEVEST DETECTED ASYSTOLE TEN DIFFERENT TIMES WHILE THE ECG SHOWED BRADYCARDIA FROM 4 TO 40 BPM DEGRADING TO ASYSTOLE. THE PT RECEIVED 5 TREATMENT DEFIBRILLATIONS BETWEEN 10:48:33 AND 15:20:55 ON (B)(6) 2014 IN RESPONSE TO ASYSTOLE. OVERSENSING OF SMALL CARDIAC SIGNAL CONTRIBUTED TO THE FALSE DETECTION. NO SUSTAINED VENTRICULAR TACHYARRHYTHMIAS WERE DETECTED. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE ENTIRE EVENT. THE DEVICE SHUTDOWN AT 16:15:41 ON (B)(6) 2014. THERE IS NO INDICATION THAT THE DEFIBRILLATIONS CONTRIBUTED TO THE PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637079 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death