BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 18788117 · Received February 27, 2024

    Report

    Report Number
    3008642652-2024-02207
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    February 18, 2024
    Report Date
    February 27, 2024
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A PAIN UNDER THE LIFEVEST EQUIPMENT. PATIENT DESCRIBED THE AREA AS PAIN UNDER ELECTRODES FROM PRESSURE AND DIGGING INTO SKIN. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT REPORTED BEING HOSPITALIZED, BUT THERE IS NO INDICATION OF MEDICAL INTERVENTION. REPORTING OUT OF THE ABUNDANCE OF CAUTION. FOLLOW UP INDICATED THAT THE DIGGING INTO SKIN IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1656956 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown