BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 19214540 · Received April 30, 2024

    Report

    Report Number
    3008642652-2024-04501
    Event Type
    Injury
    Date Received
    April 30, 2024
    Date of Event
    April 23, 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 A PATIENT DEVELOPED A DIGGING INTO SKIN UNDER THE LIFEVEST EQUIPMENT. PATIENT DESCRIBED THE AREA AS INDENTATIONS FROM WIRES DIGGING INTO SKIN CAUSING DISCOMFORT AND REDNESS. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION IT'S UNCLEAR IF THE PHYSICIAN WHO SPOKE WITH SUPPORT SERVICES, PRESCRIBED ANY CREAMS OR OINTMENTS TO THE SKIN IRRITATION. REPORTING OUT OF THE ABUNDANCE OF CAUTION. FOLLOW UP INDICATED THAT THE SKIN IRRITATION IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1992904 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown