BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 4262469 · Received November 14, 2014

    Report

    Report Number
    3008642652-2014-03842
    Event Type
    Death
    Date Received
    November 14, 2014
    Date of Event
    June 2, 2012
    Report Date
    November 10, 2014
    Manufacturer
    ZOLL MANUFACTURING CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) WERE COMPLETED. THE MONITOR AND ELECTRODE BELT WERE FULLY FUNCTIONAL UPON RECEIPT. MONITOR SN (B)(4): (B)(6) 2007. ELECTRODE BELT SN (B)(4): (B)(6) 2009.

    Description of Event or Problem · 1

    DURING A RETROACTIVE REVIEW OF PAST COMPLAINTS FOR POTENTIAL ADVERSE EVENTS, CONDUCTED AS A CAPA IN RESPONSE TO A RECENT FDA INSPECTION, A REPORTABLE ADVERSE EVENT WAS DISCOVERED. A PHYSICIAN CONTACTED A ZOLL TERRITORY MANAGER ON (B)(6) 2012 TO REPORT THAT A (B)(6) YEAR OLD MALE PT WAS TREATED BY THE LIFEVEST. A PT SERVICE REP WAS DISPATCHED AND REPORTED LATER THAT MORNING THAT THE PT HAD CODED AND THAT HOSPITAL STAFF WAS UNABLE TO REVIVE HIM. THE PT PASSED AWAY ON (B)(6) 2012 AROUND 8:00 AM. THE PT WAS IN THE HOSPITAL AT THE TIME OF PASSING. PER REVIEW OF THE TREATMENT EVENT, AT 12:27 AM ON (B)(6) 2012 THE PT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT. SVT AT 175BPM MIXED WITH NSVT CONTRIBUTED TO THE FALSE DETECTION. THE PT'S POST-SHOCK RHYTHM WAS SINUS TACHYCARDIA AT 112 BPM. THE RESPONSE BUTTONS WERE NOT USED DURING THE EVENT. THE LIFEVEST WAS SHUT DOWN AT 1:55 AM ON (B)(6) 2012. THE LIFEVEST WAS DEACTIVATED PRIOR TO PT PASSING. ZOLL CANNOT DEFINITIVELY RULE OUT THE INAPPROPRIATE TREATMENT AS A CONTRIBUTING CAUSE OF THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738740 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| H