BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 9466698 · Received December 13, 2019

    Report

    Report Number
    3008642652-2019-10095
    Event Type
    Injury
    Date Received
    December 13, 2019
    Date of Event
    April 1, 2019
    Report Date
    December 13, 2019
    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

    BIOCOMPATIBILITY TESTING TO ISO 10993 WAS SUCCESSFULLY COMPLETED ON SKIN-CONTACTING SURFACES OF THE LIFEVEST DEVICE AS WELL AS THE BLUE¿ DEFIBRILLATION GEL.

    Description of Event or Problem · 1

    A US DISTRIBUTOR REPORTED THAT A (B)(6) PATIENT DEVELOPED A "PRESSURE MARK UNDER THE VIBRATION BOX AREA." PATIENT WAS USING VAC THERAPY DUE TO WOUND HEALING DISORDER AT HIS STERNUM (STATUS POST CORONARY ARTERY BYPASS SURGERY). PATIENT WAS IN THE HOSPITAL, WHERE HE MOSTLY LIES, AND THE STAFF CONCLUDED THAT THE PATIENT WOULD REMOVE THE DEVICE AT NIGHT WHILE BEING CONNECTED TO AN EXTERNAL MONITOR SO THE AFFECTED AREA COULD ATTEMPT TO HEAL. IT WAS REPORTED THAT THE PATIENT HAD A SKIN LESION, WHICH ALREADY WAS DRESSED WITH SKIN PROTECTION PFLASTER. IT'S NOT KNOWN WHETHER THE DEVICE WAS RESPONSIBLE FOR THIS SKIN LESION OR NOT. PATIENT WAS UNDER MEDICAL CARE, THE OUTCOME OF THE IRRITATION IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264424 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| R