BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4251860 · Received November 5, 2014

    Report

    Report Number
    3008642652-2014-03608
    Event Type
    Death
    Date Received
    November 5, 2014
    Date of Event
    July 27, 2013
    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
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) WAS COMPLETED. THE MONITOR WAS FULLY FUNCTIONAL UPON RECEIPT. ELECTRODE BELT SN (B)(4) WAS NOT RETURNED FOR EVALUATION. THERE IS NO INDICATION OF ANY DEVICE MALFUNCTION. ELECTRODE BELT SN (B)(4) MANUFACTURED 01/2011.

    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. THE WIFE OF A (B)(6 ) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT PASSED AWAY ON (B)(6) 2013 AT 4:04 AM. THE PT WAS IN THE HOSPITAL AT THE TIME OF PATIENT'S PASSING. THE LIFEVEST DETECTED NSVT (220 BPM) AT 19:56:46 ON (B)(6) 2013. THE LIFEVEST DEPLOYED GEL AND DELIVERED A 134J PULSE AT 19:57:34. THE IMPEDANCE AT THE TIME OF THE TREATMENT WAS 698 OHMS. THE RHYTHM AT THE TIME OF THE SHOCK WAS VENTRICULAR COMPLEXES (120 BPM). THE PATIENT'S POST-SHOCK RHYTHM CONTINUED TO BE VENTRICULAR COMPLEXES (70 TO 140 BPM). THE RESPONSE BUTTONS WERE NOT USED DURING THE EVENT. THE ELECTRODE BELT WAS DISCONNECTED AT 19:57:37. THE LIFEVEST WAS SHUT DOWN AT 20/:28:10 ON (B)(6) 2013. THE LIFEVEST WAS DEACTIVATED PRIOR TO PATIENT PASSING. THE HIGH IMPEDANCE LIKELY RESULTED FROM THE DEVICE BEING REMOVED FROM THE PATIENT DURING THE TREATMENT. THE RESPONSE BUTTONS WERE NOT USED DURING THE EVENT. 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
    709864 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death