BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 19918493 · Received August 6, 2024

    Report

    Report Number
    3015185344-2024-00147
    Event Type
    Death
    Date Received
    August 6, 2024
    Date of Event
    August 3, 2024
    Report Date
    August 6, 2024
    Manufacturer
    KESTRA MEDICAL TECHNOLOGIES, INC.
    Product Code
    MVK
    UDI-DI
    00840241600238
    PMA / PMN Number
    P200037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION OF THE ALLEGED MALFUNCTION REQUIRED RETRIEVAL OF THE DEVICE FROM THE PATIENT; RETURN TO THE CONTRACT MANUFACTURER FOR DECONTAMINATION, INSPECTION AND INITIAL TESTING; FOLLOWED BY SHIPMENT TO THE MANUFACTURER OF RECORD FOR FAILURE INVESTIGATION AND ROOT CAUSE ANALYSIS. THERAPY CABLE WAS NOT RECOVERED FROM THE FIELD. THE RETURNED MONITOR WAS TESTED AND PASSED BOTH ISL (SAFETY) AND EIT (PERFORMANCE) TESTING. DEVICE EVENT LOG RECORD INDICATED THAT THE PATIENT WAS WEARING THE WCD SYSTEM DURING THE ASYSTOLE EPISODE ON (B)(6) 2024. WCD IS NOT INDICATED FOR THE TREATMENT OF ASYSTOLE.

    Description of Event or Problem · 0

    KMT RECEIVED REPORT THAT THE PATIENT EXPIRED WHILE STILL WEARING THE WCD SYSTEM. MDR FILED DUE TO REPORTED PATIENT DEATH. WCD ROLE IN PATIENT DEATH IS PENDING ADDITIONAL MEDICAL INFORMATION AND PENDING EVALUATION OF TO-BE-RETURNED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702383 ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MVK KESTRA MEDICAL TECHNOLOGIES, INC. 80014-002 00840241600238

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Death