BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 19215969 · Received April 30, 2024

    Report

    Report Number
    3008642652-2024-04512
    Event Type
    Injury
    Date Received
    April 30, 2024
    Date of Event
    April 25, 2024
    Report Date
    April 30, 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

    NOT APPLICABLE.

    Description of Event or Problem · 0

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT DEVELOPED A BRUISE FROM DIGGING INTO SKIN UNDER THE LIFEVEST. THE PATIENT DESCRIBED THE AREA AS A BRUISE FROM GARMENT BEING TIGHT 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. THE OUTCOME OF THE IRRITATION IS UNKNOWN AS FOLLOW UP ATTEMPTS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2131838 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown