BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3430237 · Received October 9, 2013

    Report

    Report Number
    3008642652-2013-02908
    Event Type
    Death
    Date Received
    October 9, 2013
    Date of Event
    September 9, 2013
    Report Date
    October 8, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) WAS COMPLETED. THE MONITOR AND ELECTRODE BELT WERE FULLY FUNCTIONAL UPON EVALUATION. THE LIFEVEST DETECTED VENTRICULAR FIBRILLATION WAS DETECTED AT 11:21:29 ON (B)(6) 2013 AND DEPLOYED GEL AT 11:22:33. THE LIFEVEST APPROPRIATELY DELIVERED A 150J PULSE. THE PULSE IMPEDANCE WAS 73 OHM, WHICH IS WITHIN NORMAL OPERATING PARAMETERS. THE PULSE CONVERTED THE PATIENT'S RHYTHM FROM VENTRICULAR FIBRILLATION TO ASYSTOLE (11:23:06). NOISE AND ARTIFACT CONTRIBUTED TO THE FALSE DETECTION OF THE SECOND TREATMENT. THE RESPONSE BUTTONS WERE PRESSED AND THE ELECTRODE BELT WAS DISCONNECTED BY A BYSTANDER SHORTLY AFTER THE SECOND TREATMENT WAS DELIVERED. THE LIFEVEST DEVICE FUNCTIONED NORMALLY AND WITHIN SPECIFICATIONS. THERE WAS NO PRODUCT PROBLEM WITH THE DEVICE. NO EQUIPMENT DEFICIENCIES WERE ALLEGED AGAINST THE DEVICE. POST-SHOCK ASYSTOLE IS A KNOWN RISK OF DEFIBRILLATION. DATES OF MANUFACTURE: SN (B)(4): 04/2012, SN (B)(4): 02/2013.

    Description of Event or Problem · 1

    A ZOLL BILLING SPECIALIST CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) FEMALE PATIENT'S SPOUSE NOTIFIED HER THAT THE PATIENT PASSED AWAY ON (B)(6) 2013. THE PATIENT'S SPOUSE REPORTED HE HEARD ALARMS NOTIFYING HIM A TREATMENT WAS GOING TO BE DELIVERED. THE PATIENT'S SPOUSE ALSO REPORTED THAT THE PATIENT WAS NOT ALERT DURING THE ALARMS AND THAT THE PATIENT DID NOT PRESS THE RESPONSE BUTTONS. UPON RECEIPT OF THE DEVICE, A DOWNLOAD WAS PERFORMED WHICH CONFIRMED THAT THE PATIENT RECEIVED A TREATMENT (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512187 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death