BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2189639 · Received July 29, 2011

    Report

    Report Number
    3008642652-2011-00326
    Event Type
    Death
    Date Received
    July 29, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 29, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PT DEATH) HAS BEEN INVESTIGATED. UPON EVAL, THE MONITOR WAS FULLY FUNCTIONAL. RESULTS OF DEATH ANALYSIS: THE DEVICE PROPERLY DETECTED VT/VF; HOWEVER, NO TREATMENT SEQUENCE WAS INITIATED AS THE PT'S VT (122 BPM) WAS BELOW THE PT'S PROGRAMMED VT THRESHOLD (150 BPM). WHEN THE ARRHYTHMIA DEGRADED TO ASYSTOLE, NO TREATMENT SEQUENCE WAS INITIATED AS ASYSTOLE IS CONSIDERED A NON-SHOCKABLE RHYTHM. SUBSEQUENT MONITORING OF THE PT'S RHYTHM WAS NOT POSSIBLE DUE TO DEVICE DEACTIVATION. THE DEVICE FUNCTIONED AS DESIGNED. NO TREATMENT WAS INITIATED FOR VT OR VF RHYTHMS BECAUSE THE PT'S VT WAS BELOW THE PT'S PROGRAMMED VT. IN ADDITION, THE DEVICE DID NOT TREAT ASYSTOLE BECAUSE THIS IS A NON-SHOCKABLE RHYTHM. HOWEVER, THE MONITOR SHOULD HAVE ALARMED WITH A "CALL AMBULANCE" MESSAGE WHEN THE ASYSTOLE RHYTHM WAS DETECTED. THE ALLEGED REPORT BY THE PT'S DAUGHTER THAT THE DEVICE DID NOT ALARM CANNOT BE CONFIRMED. ALL ALARMS WERE FULLY FUNCTIONAL UPON RECEIPT AT ZOLL.

    Description of Event or Problem · 1

    THE PT EXPERIENCED AN EPISODE OF VT AT 122 BPM WHICH DEGRADED TO VF. THE DEVICE PROPERLY DETECTED VT/ VF BUT NO TREATMENT SEQUENCE WAS INITIATED AS THE PT'S VT RATE WAS BELOW THE PROGRAMMED THRESHOLD OF 150 BPM. THE ARRHYTHMIA EVENTUALLY TRANSITIONED TO ASYSTOLE. THE PT PASSED WHILE IN THE HOSP. THE PT'S DAUGHTER REPORTED THAT THE SYSTEM WAS NOT ALARMING AT THE TIME OF DEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death