BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4687174 · Received April 10, 2015

    Report

    Report Number
    3008642652-2015-01794
    Event Type
    Death
    Date Received
    April 10, 2015
    Date of Event
    February 1, 2015
    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 EVAL WAS ACCOMPLISHED THROUGH A REVIEW OF THE PT'S DOWNLOADED DATA FILE. REVIEW OF THE DATE DOES NOT INDICATE ANY DEVICE MALFUNCTION RELATED TO THE PT'S DEATH. MONITOR (B)(4); ELECTRODE BELT (B)(4), MANUFACTURING DATE: 04/2012.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL ON (B)(6) 2015 TO REPORT THAT A PT PASSED AWAY ON (B)(6) 2015. REVIEW OF THE DETAILS SURROUNDING THE EVENT REVEALS THAT THE PT EXPERIENCED AN APPROPRIATE DEFIBRILLATION EVENT CONSISTING OF SIX APPROPRIATE SHOCKS FOR VENTRICULAR TACHYCARDIA / VENTRICULAR FIBRILLATION AND FOUR OTHER SHOCKS DUE TO SVT. THE RHYTHM AFTER THE LAST SHOCK REMAINED IN SVT. THE PT DEVELOPED VF APPROX 220 SECONDS AFTER THE LAST SHOCK. A SUBSEQUENT TREATMENT WAS NOT DELIVERED DUE TO THE PT RECEIVING THE MAXIMUM 5 SHOCKS IN A SINGLE TREATMENT SEQUENCE. IN ADDITION, ARTIFACT WAS LATER DETECTED ON BOTH ECG CHANNELS IN WHICH THE DEVICE DECLARED A NON-TREATABLE RHYTHM. THE ELECTRODE BELT WAS THEN DISCONNECTED. THE PT WAS REPORTEDLY UNCONSCIOUS AND NOT WEARING THE LIFEVEST AT THE TIME OF PASSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240842 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| O