BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4257366 · Received November 12, 2014

    Report

    Report Number
    3008642652-2014-03892
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    December 23, 2013
    Report Date
    November 11, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO EQUIPMENT DEFICIENCIES WERE ALLEGED AGAINST THE LIFEVEST. NO EQUIPMENT EVAL WAS PERFORMED. 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

    DURING A RETROACTIVE REVIEW OF PAST COMPLAINTS FOR POTENTIAL ADVERSE EVENTS, CONDUCTED AS A CAPA IN RESPONSE TO A RECENT FDA INSPECTION, A REPORTABLE ADVERSE EVENT WAS DISCOVERED. A (B)(6) FEMALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT SHE WAS DEVELOPING SKIN IRRITATION UNDER THE LIFEVEST. THE PT HAD RECENTLY UNDERGONE A BONE MARROW TRANSPLANT, INCREASING HER SKIN SENSITIVITY. THE PT REPORTED THAT THE IRRITATION UNDER THE GARMENT WAS CAUSING SCARRING TO HER CHEST. IT IS UNK WHETHER THE PT REQUIRED MED INTERVENTION. THE CLINICAL OUTCOME OF THE IRRITATION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729578 LIFEVEST WCD 4000 SYSTEM MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other