BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4250068 · Received November 6, 2014

    Report

    Report Number
    3008642652-2014-03664
    Event Type
    Death
    Date Received
    November 6, 2014
    Date of Event
    May 22, 2012
    Report Date
    November 3, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: UPON EVAL OF MONITOR SN (B)(4), THE MONITOR WAS FULLY FUNCTIONAL. UPON EVAL OF ELECTRODE BELT SN (B)(4), THE BELT FAILED INCOMING TESTING. THERE WAS AN OPEN WIRE IN THE CABLE CONNECTING ECG ELECTRODE A AND B. THE DAMAGED DEVICE WAS REPORTED ON MDR 3008642652-2012-01596. ZOLL'S ANALYSIS DETERMINED THAT THE BELT WAS FUNCTIONAL AND ABLE TO MONITOR DURING PT USE. THE DAMAGE OCCURRED AFTER DEVICE DEACTIVATION. THERE IS NO INDICATION THAT THE BROKEN WIRE CAUSED OR CONTRIBUTED TO THE PT'S DEATH. THE EP ALLEGATIONS WERE INVESTIGATED. THE DEVICE PROPERLY DETECT AND TREATED A VT/VF EVENT WHICH CONVERTED THE ARRHYTHMIA TO A SLOWER RHYTHM. THE TREATMENT DURING BRADYCARDIA WAS DUE TO MULTIPLE COUNTING AND SIGNAL ARTIFACT. DEVICE MFG DATE: MONITOR; BELT: 05/2011.

    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. ON (B)(4) 2012, ZOLL WAS NOTIFIED THAT A (B)(6) MALE PT PASSED AWAY SHORTLY AFTER RECEIVING LIFEVEST TREATMENT. ON (B)(6) 2012, A (B)(6) MALE PT'S EP DOCTOR REPORTED TO A ZOLL TERRITORY MGR THAT HE HAD CONCERNS ABOUT THE PT'S RECENT TREATMENT ECG STRIPS. THE DOCTOR BELIEVED THAT THE LIFEVEST INAPPROPRIATELY SHOCKED THE PT TWICE WHILE IN A SINUS BRADYCARDIA AND THAT THE LIFEVEST MAY HAVE MALFUNCTIONED. REVIEW OF THE EVENT INDICATES THAT THE PT EXPERIENCED ONE APPROPRIATE AND ONE INAPPROPRIATE DEFIBRILLATION. THE FIRST SHOCK SUCCESSFULLY CONVERTED THE VT/VF ARRHYTHMIA TO A SLOWER RHYTHM BY ONE 150J SHOCK. SINGLE ARTIFACT AND MULTIPLE COUNTING THEN CONTRIBUTED TO THE FALSE DETECTION DURING BRADYCARDIA. THE POST SHOCK RHYTHM WAS SEVERE BRADYCARDIA TRANSITIONING TO ASYSTOLE. THE PT'S RHYTHM REMAINED IN BRADYCARDIA FOR AN ADDITIONAL 4 MINUTES WHEN THE ELECTRODE BELT WAS DISCONNECTED. FURTHER MONITORING WAS NOT POSSIBLE. THE RESPONSE BUTTONS WERE NOT USED DURING THE ENTIRE EVENT. THE PT EXPIRED ABOUT ONE HALF HOUR LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714289 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death