BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE EZ

    MDR report key: 19315285 · Received May 14, 2024

    Report

    Report Number
    2124215-2024-29376
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 19, 2024
    Report Date
    May 14, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P910073/S026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    KADOSAKA, TAKEHIDE, ET AL. (2024). NORMALIZATION OF INCREASING SHOCKING COIL IMPEDANCE WITH FULL OUTPUT SYNCHRONIZED SHOCK. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY MANUSCRIPT ID JCE-24-0337.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TECHNICAL SERVICES (TS) WAS CONTACTED BY THE HEALTH CARE PROFESSIONAL (HCP) TO REVIEW A JOURNAL ARTICLE. IN THE ARTICLE, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 200 OHMS. CHEST RADIOGRAPHY SHOWED NO MACROSCOPIC APPEARANCES OF A LEAD INSULATION BREACHES. AFTER A DELIVERED SHOCK, THE IMPEDANCE MEASURED 65 OHMS AND REMAINED THERE FOR FIVE YEARS. TS AND THE HCP DISCUSSED IT WAS LIKELY THE SINGLE OUT-OF-RANGE IMPEDANCE MEASUREMENT WAS THE RESULT OF ELECTROMAGNETIC INTERFERENCE (EMI). THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476064 ENDOTAK ENDURANCE EZ IMPLANTABLE LEAD LWS BOSTON SCIENTIFIC CORPORATION 0154

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male