BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDIS

    MDR report key: 18397272 · Received December 27, 2023

    Report

    Report Number
    1000165971-2023-01067
    Event Type
    Malfunction
    Date Received
    December 27, 2023
    Date of Event
    November 28, 2023
    Report Date
    January 11, 2024
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    LWS
    UDI-DI
    08031527018454
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY MICROPORT CRM THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES. REVIEW OF THE PROVIDED FILES REVEALED: ON (B)(6) 2023, A DTF WAS PERFORMED BY INDUCING A VF BY A SHOCK ON T WAVE O A FIRST SHOCK (PROGRAMMED AT 32J) WAS DELIVERED 22,9 J BY THE ICD WITH A SHOCK IMPEDANCE AT 189 O A SECOND SHOCK (PROGRAMMED AT 42J) WAS DELIVERED 31,9J BY THE ICD WITH A SHOCK IMPEDANCE AT 162 O NONE OF THESE SHOCKS STOPPED THE VF. O FOR BOTH SHOCKS, THE TOTAL ENERGY WASN¿T DELIVERED DUE TO A SHOCK IMPEDANCE SUPERIOR TO 150 O AN EXTERNAL SHOCK WAS DELIVERED AND STOPPED THE VF - NO OVERCONSUMPTION WAS RECORDED. - BETWEEN (B)(6) 2023, RIGHT VENTRICULAR LEAD IMPEDANCE IS STABLE WITHIN NORMAL RANGE. RV AND SVC COIL IMPEDANCE ARE SLIGHTLY FLUCTUATING WITHIN NORMAL RANGE.

    Additional Manufacturer Narrative · 0

    PLEASE REFER TO THE ATTACHED REPORT -REVIEW OF THE PROVIDED DATA REVEALED DUE TO A HIGH IMPEDANCE SHOCK, THE ENERGY SHOCK WAS PARTIALLY DELIVERED. BASED ON AVAILABLE DATA, NO ISSUE IS SUSPECTED ON THE ICD DEVICE. THE PROPER FUNCTION OF THE VENTRICULAR LEAD SHOULD BE ASSESSED.

    Description of Event or Problem · 0

    REPORTEDLY, A DFT WAS UNDERTAKEN ON THE (B)(6) 2023. TWO SHOCKS WERE UNSUCCESSFUL AT 32J AND AT 42J AND A RESCUE SHOCK WAS DELIVERED BY EXTERNAL DEFIBRILLATOR. LOW ENERGY WAS DELIVERED AND BOTH SHOCK IMPEDANCES WERE RELATIVELY HIGH.

    Description of Event or Problem · 0

    REPORTEDLY, A DFT WAS UNDERTAKEN ON THE (B)(6) 2023. TWO SHOCKS WERE UNSUCCESSFUL AT 32J AND AT 42J AND A RESCUE SHOCK WAS DELIVERED BY EXTERNAL DEFIBRILLATOR. LOW ENERGY WAS DELIVERED AND BOTH SHOCK IMPEDANCES WERE RELATIVELY HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570641 EDIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MICROPORT CRM S.R.L. EDIS DF4 DR - 2440 08031527018454

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention