BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10701451 · Received October 19, 2020

    Report

    Report Number
    3008642652-2018-06137
    Event Type
    Death
    Date Received
    October 19, 2020
    Date of Event
    May 28, 2018
    Report Date
    July 13, 2018
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    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 OF BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT DEATH/TREATMENT) WAS CONFIRMED. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE ECG ELECTRODES, FOLLOWED BY A 5HZ SIMULATED TREATABLE ARRHYTHMIA SIGNAL WHICH VERIFIED PROPER PERFORMANCE OF THE DETECTION ALGORITHM. THE PULSE DELIVERY CIRCUITRY TEST VERIFIED PROPER DELIVERY OF A FULL ENERGY 150J BIPHASIC PULSE. THE FUNCTIONAL TESTING CONFIRMED PROPER ECG ACQUISITION AND PULSE DELIVERY FUNCTIONALITY. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT DEATH) HAS BEEN CONFIRMED. UPON INVESTIGATION THE MONITOR WAS NOT PROPERLY PRODUCING A DRIVEN GROUND SIGNAL. THE CAUSE FOR THE FAILURE WAS ISOLATED TO AN OPEN R781 DRIVEN GROUND RESISTOR ON THE COMPUTER/ANALOG BOARD. AN OPEN R781 RESISTOR IS CONSISTENT WITH DAMAGE OBSERVED WHEN A PATIENT IS EXTERNALLY DEFIBRILLATED WHILE WEARING A LIFEVEST DEVICE. THE OPEN RESISTOR WAS CONSISTED WITH DAMAGE CAUSED BY EXTERNAL DEFIBRILLATION.

    Description of Event or Problem · 1

    ON 10/16/2020: RESUBMITTING THIS MDR AS PART OF AN INTERNAL AUDIT WHERE THE ELECTRONIC 3500A PDF FORM COULD NOT BE LOCATED. THE INTERNAL AUDIT INDICATES THAT THE ELECTRONIC 3500A FORM, WITHIN THE ESUBMITTER APPLICATION, WAS CREATED ON 07/13/2018. ACKNOWLEDGEMENTS 1, 2, AND 3 COULD NOT BE LOCATED. A US DISTRIBUTOR CONTACTED ZOLL AND REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2018. A REVIEW OF THE PATIENT'S CONTINUOUS ECG DOWNLOAD INDICATED THAT THE PATIENT RECEIVED 15 NON-LIFEVEST EXTERNAL DEFIBRILLATION SHOCKS PRIOR TO PASSING. THE PATIENT EXPERIENCED NSVT ON (B)(6) 2018 AT 06:34:00. THE PATIENT TRANSITIONED TO SVT AND WAS TREATED, WITH A POST-SHOCK RHYTHM OF SVT. THE PATIENT WAS THEN TREATED TWO ADDITIONAL TIMES WHILE STILL IN SVT. THE PATIENT THEN DEGRADED TO VF FOR 18 SECONDS, AND WAS TREATED A FOURTH TIME WITH A POST SHOCK RHYTHM OF VF. CPR WAS INITIATED 12 SECONDS LATER WITH UNDERLYING VF. THE CPR ARTIFACT CONTINUED FOR 4 MINUTES, WHEN THEN THE PATIENT RECEIVED A FIFTH TREATMENT WITH A POST SHOCK RHYTHM OF SVT. THE PATIENT THEN DEGRADED TO VF FOR 16 SECONDS AND WAS TREATED WITH A POST SHOCK RHYTHM OF A SINUS RHYTHM DEGRADING TO VF. 10 SECONDS LATER, THE PATIENT WAS TREATED A SEVENTH TIME WITH A POST SHOCK RHYTHM OF VF WITH CPR ARTIFACT. 10 SECONDS LATER THE PATIENT RECEIVED AN EIGHT TREATMENT WITH A POST SHOCK RHYTHM OF NSVT DEGRADING TO VF. THE PATIENT THEN WAS GIVEN A NINTH TREATMENT 4 SECONDS LATER WITH A POST SHOCK RHYTHM NSVT WITH CPR ARTIFACT. THE PATIENT REMAINED IN CPR ARTIFACT FOR 4 MINUTES, AND RECEIVED A TENTH TREATMENT WITH A POST SHOCK SINUS RHYTHM AT 100 BPM. THE PATIENT DEGRADED TO VF FOR 30 SECONDS AND WAS TREATED WITH A POST SHOCK RHYTHM OF VT AT 240 BPM. THE PATIENT RECEIVED AN ELEVENTH TREATMENT DURING VF 30 SECONDS LATER, WITH A POST SHOCK RHYTHM OF VT. SHORTLY AFTER THE PATIENT RECEIVED A TWELFTH AND THIRTEENTH TREATMENT WHILE IN VT. CPR ARTIFACT WAS EVIDENT. THE PATIENT DEGRADED TO VF AND RECEIVED A FOURTEENTH TREATMENT WITH A POST SHOCK RHYTHM OF CPR ARTIFACT. THE PATIENT RECEIVED A FIFTEENTH TREATMENT WHILE IN VF WITH CPR ARTIFACT. THE PATIENT REMAINED IN VF WITH CPR ARTIFACT UNTIL DEVICE DEACTIVATION AT 07:22:05 ON (B)(6) 2018. THE PATIENT SUBSEQUENTLY PASSED AWAY ON (B)(6) 5018. ALL OF THE TREATMENT SHOCKS WERE EXTERNAL DEFIBRILLATION SHOCKS, AND WERE NOT DELIVERED BY THE LIFEVEST. TREATMENTS 1, 2, 3, 5, 9, AND 10 WERE INAPPROPRIATE EXTERNAL DEFIBRILLATION SHOCKS. THESE WERE DELIVERED WHILE THE PATIENT WAS IN A NON-TREATABLE RHYTHM. ARRHYTHMIAS DURING TREATMENTS 4, 6, 7, AND 8 WERE NOT LONG ENOUGH TO BE TREATED BY THE LIFEVEST. THE SHORTEST AMOUNT OF TIME FOR A VF ARRHYTHMIA TO BE TREATED BY THE LIFEVEST IS 30 SECONDS. TREATMENTS 11, 12, 13, 14, AND 15 WERE NOT TREATED BY THE LIFEVEST DUE TO CPR ARTIFACT AS ACTIVE RESUSCITATION EFFORTS WERE BEING MADE ON THE PATIENT. THE ARTIFACT PRECLUDED THE DEVICE FROM DELIVERING TREATMENT SHOCKS. THERE WERE NO ALLEGATIONS TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159870 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death