BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4661995 · Received April 3, 2015

    Report

    Report Number
    3008642652-2015-01795
    Event Type
    Death
    Date Received
    April 3, 2015
    Date of Event
    July 9, 2014
    Report Date
    April 1, 2015
    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 MFR DATE: MONITOR SN (B)(4) - 11/2010 (REUSE); ELECTRODE BELT SN (B)(4) -04/2012 (REUSE). DEVICE EVALUATION OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) IS COMPLETE. UPON RECEIPT, BOTH THE MONITOR AND BELT WERE FULLY FUNCTIONAL .

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A (B)(6) MALE PATIENT PASSED AWAY ON (B)(6) 2014. PRIOR TO PASSING, THE PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT. REVIEW OF THE EVENT REVEALS THE PATIENT WAS TREATED 14 TIMES BETWEEN 20:27:23 AND 20:45:48 DURING ASYSTOLE. THE POST-SHOCK RHYTHMS WERE ASYSTOLE. OVER-SENSING OF SMALL CARDIAC SIGNAL CONTRIBUTED THE FALSE DETECTIONS. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE ENTIRE EVENT. THE PATIENT PASSED AWAY THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220606 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death