BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6125895 · Received November 23, 2016

    Report

    Report Number
    3008642652-2016-08645
    Event Type
    Death
    Date Received
    November 23, 2016
    Date of Event
    September 30, 2016
    Report Date
    November 22, 2016
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) IS CURRENTLY UNDERWAY. DEVICE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT. THE REVIEW OF THE SOFTWARE FLAGS CONSISTED OF AN ANALYSIS OF THE DOWNLOADED DATA TO IDENTIFY ANY FAULT FLAGS OR UNUSUAL PATTERNS OF SOFTWARE FLAGS. THE SOFTWARE FLAG FILES DID NOT SUGGEST A DEVICE MALFUNCTION THAT WOULD CONTRIBUTE TO THE PATIENT'S DEATH. BASED ON AVAILABLE INFORMATION THERE IS NO INDICATION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT PASSED AWAY ON (B)(6) 2016 WHILE WEARING THE LIFEVEST. THE PATIENT WAS REPORTED TO BE UNCONSCIOUS AND AT HOME WHEN THE MONITOR ALARMED. THE PATIENT EXPERIENCED AN APPROPRIATE TREATMENT EVENT CONSISTING OF THREE SHOCKS. AT 03:06:29 THE DEVICE DELIVERED ONE SHOCK WHILE THE PATIENT WAS IN VENTRICULAR FIBRILLATION. THE POST SHOCK RHYTHM WAS ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY. AT 3:03:53 A SECOND SHOCK WAS DELIVERED WHILE THE PATIENT WAS IN ASYSTOLE. OVERSENSING OF A LOW-AMPLITUDE CARDIAC SIGNAL CONTRIBUTED TO THE FALSE DETECTION. AT 03:25:21 A THIRD SHOCK WAS DELIVERED WHILE THE ECGS SHOWED CPR ARTIFACT. THE ELECTRODE BELT WAS DISCONNECTED 03:25:46. THE PATIENT SUBSEQUENTLY PASSED AWAY. POST-SHOCK ASYSTOLE IS A KNOWN POTENTIAL OUTCOME OF DEFIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775938 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death