BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6136605 · Received November 30, 2016

    Report

    Report Number
    3008642652-2016-08760
    Event Type
    Death
    Date Received
    November 30, 2016
    Date of Event
    October 22, 2016
    Report Date
    November 30, 2016
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) IS COMPLETE. UPON EVALUATION, THE ELECTRODE BELT FAILED INCOMING FUNCTIONALITY TESTING. UPON INVESTIGATION THE ELECTRODE BELT WAS UNABLE TO COMMUNICATE WITH A MONITOR. THE CAUSE FOR THE FAILURE WAS ISOLATED TO TRUNK CABLE CONNECTOR J702 ON THE DISTRIBUTION NODE PCA. THE J702 CONNECTOR WAS PHYSICALLY PULLED FROM THE PCA. THE ROOT CAUSE FOR THE DAMAGED CONNECTOR WAS EXCESSIVE FORCE ON THE TRUNK CABLE. THERE IS NO INDICATION THAT THE MALFUNCTION CONTRIBUTED TO THE INAPPROPRIATE TREATMENT OR THE PATIENT'S DEATH. DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT TREATMENT/DEATH) WAS CONFIRMED. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE MONITOR, FOLLOWED BY A 5HZ SIMULATED TREATABLE ARRHYTHMIA SIGNAL WHICH VERIFIED PROPER PERFORMANCE OF THE DETECTION ALGORITHM. DURING THE TRANSITION TO THE 5HZ SIGNAL, THE DEVICE WAS CONFIRMED TO PROPERLY ENTER INTO A TREATMENT SEQUENCE WHICH INCLUDES A VERIFICATION OF THE AUDIO MESSAGING AND SIREN ALARMS, AS WELL AS A TEST OF THE PULSE DELIVERY CIRCUITRY. THE PULSE DELIVERY CIRCUITRY TEST VERIFIED PROPER CHARGING OF THE HIGH VOLTAGE CAPACITORS AND PROPER DELIVERY OF FIVE FULL ENERGY 150J BIPHASIC PULSES. THE FUNCTIONAL TESTING CONFIRMED PROPER RESPONSE BUTTON FUNCTIONALITY, ECG ACQUISITION, DETECTION ALGORITHM PERFORMANCE, AND PULSE DELIVERY FUNCTIONALITY OF THE DEVICE. DEVICE MANUFACTURE DATE: MONITOR: SN (B)(4): 12/13/2012 REUSE; ELECTRODE BELT: SN (B)(4): 08/20/2014 REUSE.

    Description of Event or Problem · 1

    ZOLL WAS NOTIFIED BY A US DISTRIBUTOR THAT A PATIENT PASSED AWAY ON (B)(6) 2016 AFTER EXPERIENCING A TREATMENT EVENT. IT WAS REPORTED THAT THE PATIENT'S WIFE WAS PRESENT. THE RESPONSE BUTTONS WERE PRESSED EARLIER IN THE DETECTION SEQUENCE BUT NOT IMMEDIATELY PRIOR TO TREATMENT DELIVERY. THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. THE PATIENT'S WIFE CALLED EMS. PARAMEDICS ATTEMPTED RESUSCITATION AND TRANSPORTED THE PATIENT TO THE HOSPITAL. A REVIEW OF THE EVENT REVEALED THAT THE PATIENT WAS TREATED BY THE LIFEVEST PRIOR TO PASSING. REVIEW OF THE TREATMENT EVENT REVEALED THAT THE PATIENT RECEIVED 6 TREATMENTS ON (B)(6) 2016. THE PATIENT WAS TREATED APPROPRIATELY TWICE WITH A RHYTHM OF VENTRICULAR FIBRILLATION (VF). THE ARRHYTHMIA CONVERTED TO A SLOWER RHYTHM. THE PATIENT THEN RECEIVED ONE INAPPROPRIATE TREATMENT WITH A RHYTHM OF BRADYCARDIA AT 40 BEATS PER MINUTE (BPM). THE POST-SHOCK RHYTHM OF THE INAPPROPRIATE TREATMENT WAS BRADYCARDIA AT 55 BPM. OVERSENSING OF LOW-AMPLITUDE CARDIAC SIGNAL CONTRIBUTED TO THE FALSE DETECTION. THE PATIENT THEN RECEIVED AN ADDITIONAL THREE APPROPRIATE TREATMENTS WITH A RHYTHM OF VF. THE POST-SHOCK RHYTHM OF THE SIXTH TREATMENT WAS BRADYCARDIA AT 35 BPM. THE ELECTRODE BELT WAS THEN DISCONNECTED WHILE THE PATIENT'S ECG RHYTHM WAS CPR ARTIFACT. THE PATIENT LATER PASSED AWAY ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785020 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death