BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6123908 · Received November 23, 2016

    Report

    Report Number
    3008642652-2016-08586
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 16, 2016
    Report Date
    November 22, 2016
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: THE PATIENT'S LIFEVEST WAS NOT RETURNED FOR EVALUATION. BIOCOMPATIBILITY TESTING TO ISO 10993 WAS SUCCESSFULLY COMPLETED ON SKIN-CONTACTING SURFACES OF THE LIFEVEST DEVICE AS WELL AS THE BLUE(TM) DEFIBRILLATION GEL.

    Description of Event or Problem · 1

    A U.S. DISTRIBUTOR REPORTED THAT THE PATIENT HAD DEVELOPED A BLISTER ON HER BACK UNDER THE THERAPY ELECTRODES. THE PATIENT'S PHYSICIAN HELPED TO ADJUST THE GARMENT AWAY FROM THE IRRITATION. THE PATIENT REPORTED THAT THE IRRITATION IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774568 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention