BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2787069 · Received October 5, 2012

    Report

    Report Number
    3008642652-2012-02624
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    August 8, 2012
    Report Date
    October 2, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATIONS OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON EVALUATION, THE MONITOR WAS FULLY FUNCTIONAL AND WITHIN SPECIFICATIONS. BELT SN (B)(4) HAS NOT YET BEEN RETURNED. THERE IS NO INDICATION OF BELT FAILURE. TREATMENT ANALYSIS CONCLUDES THE PT RECEIVED ONE APPROPRIATE FULL ENERGY 150J SHOCK. HOWEVER, THE RHYTHM AFTER THE SHOCK WAS ASYSTOLE. DEATH ANALYSIS CONCLUDES THE DEVICE PROPERLY DETECTED AND ALARMED FOR ASYSTOLE AND BRADYCARDIA. NO TREATMENT SEQUENCE WAS INITIATED FOR ASYSTOLE OR BRADYCARDIA, AS THESE ARE CONSIDERED NON-SHOCKABLE RHYTHMS. POST-SHOCK ASYSTOLE IS A KNOWN POTENTIALLY ADVERSE OUTCOME OF DEFIBRILLATION THERAPY. DEVICE MANUFACTURE DATE: MONITOR: 03/2012, BELT: 03/2012.

    Description of Event or Problem · 1

    A (B)(6) MALE PT'S NEIGHBOR CONTACTED ZOLL LOGISTICS THAT THE PT HAD RECEIVED A TREATMENT AND PASSED WHILE WEARING THE LIFEVEST. DURING INVESTIGATION INTO THE PT'S TREATMENT AND DEATH, IT WAS DETERMINED BY ZOLL CLINICAL AFFAIRS THAT THE PT RECEIVED ONE APPROPRIATE TREATMENT SHOCK, BUT THE RHYTHM IMMEDIATELY AFTER THE SHOCK WAS ASYSTOLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death