BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4734167 · Received April 24, 2015

    Report

    Report Number
    3008642652-2015-02586
    Event Type
    Death
    Date Received
    April 24, 2015
    Date of Event
    March 13, 2015
    Report Date
    April 23, 2015
    Manufacturer
    ZOLL MANUFACTURING CORP
    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) HAS BEEN COMPLETED. AS RECEIVED, THE MONITOR FAILED INCOMING TESTING. UPON EVALUATION, THE MONITOR LACKED A DRIVEN GROUND SIGNAL. THE CAUSE OF THE LACK OF DRIVEN GROUND SIGNAL IS AN OPEN DRIVEN GROUND RELAY RESISTOR R781 ON THE COMPUTER / ANALOG BOARD. THE CAUSE OF THE OPEN RESISTOR IS THE EXTERNAL DEFIBRILLATION DELIVERED DURING THE EVENT. THERE IS NO INDICATION THAT THE OPEN RESISTOR CAUSED OR CONTRIBUTED TO THE PT'S DEATH. THE LIFEVEST WAS ABLE TO DELIVER EIGHT FULL ENERGY APPROPRIATE SHOCKS BEFORE THE ELECTRODE BELT WAS DISCONNECTED. DEVICE EVALUATION OF BELT SN (B)(4) WAS ACCOMPLISHED THROUGH A REVIEW OF THE PT'S DOWNLOADED DATA FILE. REVIEW OF THE DATA DOES NOT INDICATE ANY DEVICE MALFUNCTION RELATED TO THE EVENT. MONITOR: 05/01/2013. ELECTRODE BELT: 05/01/2011.

    Description of Event or Problem · 1

    A US DISTRIBUTOR NOTIFIED ZOLL ON (B)(6) 2015 TO REPORT THAT A PT PASSED AWAY AT THE HOSPITAL. REVIEW OF THE EVENTS SURROUNDING TH E PT'S DEATH INDICATE THAT THE PT EXPERIENCED AN APPROPRIATE DEFIBRILLATION EVENT CONSISTING OF EIGHT SHOCKS DURING VT-VF. THE RHYTHMS AT SHOCKS ONE THROUGH SIX WERE CONVERTED BUT TRANSITIONED BACK INTO VT/VF. THE RHYTHMS AT SHOCKS SEVEN AND EIGHT REMAINED IN VF. THE ELECTRODE BELT WAS DISCONNECTED. IT WAS ALSO REPORTED THAT MANUAL EXTERNAL DEFIBRILLATION WAS DELIVERED 15 TIMES DURING THE EVENT. REVIEW OF TH E PT'S ECG CAPTURED THREE NON-LIFEVEST SHOCKS AFTER SHOCKS TWO, THREE, AND FOUR. A ZOLL REPRESENTATIVE REPORTED THAT THE HOSPITAL WAS UNABLE TO LOCATE THE ELECTRODE BELT FOR RETURN FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274621 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death