BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1016933 · Received March 20, 2008

    Report

    Report Number
    3002158293-2008-00128
    Event Type
    Death
    Date Received
    March 20, 2008
    Date of Event
    February 20, 2008
    Report Date
    March 20, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFG DEVICE MONITOR: 11/2007. ELECTRODE BELT - 12/2005. DEVICE EVALUATIONS OF MONITOR AND ELECTRODE BELT HAVE BEEN COMPLETED. MONITOR WAS FOUND TO BE FUNCTIONALLY NORMAL. THE ELECTRODE BELT HAD AN OPEN R2. R2 IS THE RESISTOR THAT IS PART OF THE DRIVEN GROUND RELAY CIRCUIT. IF AN EXTERNAL SHOCK IS DELIVERED, IT PROTECTS THE MONITOR FROM RECEIVING THE FULL SHOCK. IT WAS REPAIRED. THEY WERE RETESTED AND RESTOCKED. CONCLUSIONS: VENTRICULAR ARRHYTHMIAS WERE PROPERLY DETECTED BY THE LIFEVEST, WHICH APPEARED TO OPERATE AS DESIGNED. CPR BY MEDICAL PERSONNEL, UNDOUBTEDLY APPROPRIATE, BOTH PREVENTED PROPER LIFEVEST DEFIBRILLATION ATTEMPTS AND CREATED INAPPROPRIATE LIFEVEST DETECTIONS. THE PT HAD LIFE-THREATENING BRADYARRHYTHMIA AND TACHYARRHYTHMIA EPISODES.

    Description of Event or Problem · 1

    LIFECOR BILLING WAS DOING VEST CALLS IN 2008 TO DISCUSS CHANGES IN INSURANCE AND THE FAMILY STATED THE PT HAD PASSED AWAY. LIFECOR CUSTOMER SUPPORT SPOKE TO THE PT'S SON WHO HAD TRAVELED TO THE PT'S HOUSE AND ASKED IF THE PT WAS WEARING THE DEVICE AT THE TIME OF DEATH. THE PT'S SON WAS UNFAMILIAR WITH THE DEVICE. THE PT'S WIFE WAS CONTACTED ON 02/27/2008, 02/29/2008, 03/03/2008, AND 03/04/2008. THE SYS WAS RETURNED TO LIFECOR ON 03/06/2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death