BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4762869 · Received May 8, 2015

    Report

    Report Number
    3008642652-2015-03022
    Event Type
    Death
    Date Received
    May 8, 2015
    Date of Event
    January 15, 2014
    Report Date
    May 7, 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) AND BELT SN (B)(4) WAS COMPLETED. THE MONITOR AND BELT WERE FUNCTIONAL AND ABLE TO DETECT AND TREAT A PT. MONITOR SN (B)(4) - 072013 - REUSE. ELECTRODE BELT SN (B)(4) - 08/2013 - REUSE.

    Description of Event or Problem · 1

    DURING A RETROACTIVE REVIEW OF PAST TREATMENT EVENTS FOR POTENTIAL ADVERSE EVENTS, CONDUCTED AS A CAPA IN RESPONSE TO A RECENT FDA INSPECTION, A REPORTABLE ADVERSE EVENT WAS DISCOVERED. A ZOLL TERRITORY MGR REPORTED THAT A (B)(6) YEAR OLD FEMALE PT PASSED AWAY ON (B)(6) 2014. A REVIEW OF THE EVENT INDICATES THAT THE PT EXPERIENCED SEVEN APPROPRIATE AND SIX INAPPROPRIATE TREATMENT DEFIBRILLATION SHOCKS BETWEEN 21:11:48 AND 21:35:12 ON THE DAY OF PASSING. TREATMENT SHOCKS ONE, THREE, FOUR, FIVE, SIX, SEVEN, AND THIRTEEN WERE ALL APPROPRIATE IN RESPONSE TO VENTRICULAR TACHYCARDIA (VT) OR VENTRICULAR FIBRILLATION (VF), BOTH TREATABLE RHYTHMS. ASYSTOLE AND NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) CONTRIBUTED TO THE FALSE DETECTION OF THE OTHER TREATMENT SHOCKS. THE POST-SHOCK RHYTHM OF THE FINAL TREATMENT SHOCK WAS BRADYCARDIA TRANSITIONING TO IDIOVENTRICULAR RHYTHM. THE PT WAS AT HOME, AND THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE ENTIRE EVENT. THE DEVICE WAS SHUTDOWN AT 21:52:40 ON (B)(6) 2014 WHILE THE PT WAS IN A LIFE-SUSTAINING RHYTHM. THE PT LATER PASSED AWAY WHILE NOT WEARING THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302891 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death