BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 19959844 · Received August 12, 2024

    Report

    Report Number
    3008642652-2024-08199
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 12, 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'S PRE-EXISTING CONDITION OF A STERNOTOMY WAS EXACERBATED BY THE LIFEVEST EQUIPMENT. PATIENT DESCRIBED THE AREA AS A HOLE CREATED ON STERNOTOMY SCAR FROM CLASPS DIGGING INTO THE PATIENT¿S SKIN. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT¿S WOUND CARE SPECIALIST APPLIED MEDICATION TO THE AREA AND APPLIED A SOCK AROUND THE CLASP TO PREVENT IT FROM DIGGING INTO AND RUBBING THE SKIN. THE PATIENT WAS TESTED FOR STAPH INFECTIONS, BUT THE TESTS WERE INCONCLUSIVE. FOLLOW UP INDICATED THAT THE SKIN IRRITATION IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724015 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown