BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 8578964 · Received May 3, 2019

    Report

    Report Number
    3008642652-2019-03306
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    April 18, 2019
    Report Date
    April 29, 2019
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    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(TM) DEFIBRILLATION GEL.

    Description of Event or Problem · 1

    A US DISTRIBUTOR REPORTED THAT A PATIENT HAD A SKIN IRRITATION UNDER ONE OF THE THERAPY ELECTRODES ON HER BACK. THE AREA WAS DESCRIBED AS 1 BY 2 INCHES AND AS A RED, ITCHY, AND BUMPY RASH. THE PATIENT REPORTED HAVING SENSITIVE SKIN. THE PATIENT'S DOCTOR PRESCRIBED A STEROID CREAM TO TREAT THE IRRITATION. DURING A FOLLOW-UP, THE PATIENT INDICATED THAT THE IRRITATION HAD IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370526 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R