BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4792607 · Received May 20, 2015

    Report

    Report Number
    3008642652-2015-03267
    Event Type
    Injury
    Date Received
    May 20, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 14, 2015
    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

    BIOCOMPATIBILITY TESTING TO ISO 10993 WAS SUCCESSFULLY COMPLETED ON SKIN-CONTACTING SURFACES OF THE LIFEVEST DEVICE.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED AN IRRITATION UNDER THE THERAPY ELECTRODES. FOLLOW UP INDICATED THAT THE PATIENT'S PHYSICIAN PRESCRIBED TRIAMCINOLONE LOTION FOR THE IRRITATION. THERE IS NO FURTHER INFORMATION AVAILABLE ON THE CONDITION OF THE IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327349 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R