BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1974644 · Received January 26, 2011

    Report

    Report Number
    3002158293-2011-00088
    Event Type
    Death
    Date Received
    January 26, 2011
    Date of Event
    January 9, 2011
    Report Date
    January 25, 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 EVALUATIONS OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) HAVE BEEN COMPLETED. THE REPORTED PROBLEM (PT DEATH/TREATMENT) WAS INVESTIGATED. UPON EVAL, BOTH THE MONITOR AND ELECTRODE BELT WERE FULLY FUNCTIONAL. THE PT WAS APPROPRIATELY TREATED, BUT THE RHYTHM WAS NOT SUCCESSFULLY CONVERTED TO A LIFE-SUSTAINING RHYTHM DUE TO IMPROPER LIFEVEST-BODY CONTACT. THE IMPROPER PLACEMENT ALSO CAUSED TWO OF THE APPROPRIATE SHOCKS TO DELIVER LOW-ENERGY PULSES (8 JOULES). THE PT ALSO RECEIVED TWO INAPPROPRIATE TREATMENTS. THE PT WAS INAPPROPRIATELY TREATED BECAUSE THE PT DID NOT USE THE RESPONSE BUTTONS PROPERLY DURING ARRHYTHMIA DETECTION CAUSED BY A COMBINATION OF SIGNAL ARTIFACT, NON-SUSTAINED VT, AND DOUBLE COUNTING. THE ROOT CAUSE FOR THE SIGNAL ARTIFACT WAS LIKELY POOR ELECTRODE PLACEMENT IN THE GARMENT. FIFTEEN MINUTES AFTER THE LAST VISIBLE ECG (SHOWING A LIFE-SUSTAINING RHYTHM), THE PT'S RHYTHM TRANSITIONED TO ASYSTOLE, A NON-TREATABLE RHYTHM. THE PT DEATH WAS REPORTEDLY DUE TO A SEIZURE.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT'S FRIEND CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT SERVICE TO REPORT THAT THE PT DIED ON (B)(6) 2011 WHILE WEARING THE LIFEVEST. SHE REPORTED THAT THE LIFEVEST ALARMED AND THE PT PRESSED THE RESPONSE BUTTONS. THE PT LATER RECEIVED A TREATMENT. A MESSAGE ON THE MONITOR THEN STATED TO CALL 911. THE PARAMEDICS ARRIVED AND PRONOUNCED THE PT DEAD DUE TO SEIZURE.

    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 30 YR