BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3952038 · Received July 17, 2014

    Report

    Report Number
    3008642652-2014-02168
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    July 14, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. UPON INVESTIGATION THE MONITOR AND ELECTRODE BELT WERE FULLY FUNCTIONAL. NO PROBLEMS WERE FOUND WITH THE DEVICE. THE MONITOR'S AUDIO AND TACTILE ALARMS WERE FULLY FUNCTIONAL. THE ELECTRODE BELT APPROPRIATELY DEPLOYED DEFIBRILLATOR GEL PRIOR TO THE TREATMENT EVENT. A REVIEW OF THE EVENT DETERMINED THAT THE PATIENT WAS TREATED ONCE BY THE LIFEVEST ON (B)(6) 2014, AT 10:27:05 AM, DUE TO MOTION ARTIFACT. THE RESPONSE BUTTONS WERE PRESSED INTERMITTENTLY AFTER THE TREATMENT OCCURED. THE ROOT CAUSE FOR THE MOTION ARTIFACT NOT BE POSITIVELY IDENTIFIED, BUT THE ARTIFACT EVENT MAY HAVE BEEN CAUSED BY A LOOSE GARMENT THAT RESULTED IN ECG ELECTRODE MOVEMENT. THE PATIENT WAS CONSCIOUS AT THE TIME OF THE EVENT. THE PATIENT CONTINUES TO WEAR THE DEVICE. DEVICE MANUFACTURE DATE: MONITOR SN (B)(4): 07/01/2009. ELECTRODE BELT SN (B)(4): 05/01/2013.

    Description of Event or Problem · 1

    ZOLL WAS CONTACTED BY A US DISTRIBUTOR TO REPORT THAT, SOMETIME AFTER BEING TREATED BY THE LIFEVEST, AN (B)(6) YEAR OLD MALE PATIENT REPORTED BEING THROWN BY THE TREATMENT AND EXPERIENCED BRUISING AND A BUMP ON HIS HEAD. LATER THE PATIENT REPORTED LOSING CONSCIOUSNESS, VISION IMPAIRMENT, HEADACHES, AND FOOT PAIN. FOLLOWING THE TREATMENT, THE PATIENT SOUGHT FOLLOW-UP CARE WITH HIS EYE DOCTOR, CARDIOLOGIST AND SURGEON. THE PATIENT ALLEGED THERE WERE NO ALARMS (TACTILE OR AUDIBLE) WARNING OF THE PENDING TREATMENT. THE PATIENT CONTINUES TO WEAR THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420108 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other