BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE SG

    MDR report key: 18974522 · Received March 25, 2024

    Report

    Report Number
    2124215-2024-17946
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    October 8, 2022
    Report Date
    March 25, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    PMA / PMN Number
    P910073/S077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS SOME TYPE OF EXTRA SIGNALS PRESENT ON THE RIGHT VENTRICULAR CHANNEL OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE SIGNALS WERE SENSED AND LED TO THE ICD STORING EPISODES OF NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT). SINCE JUNE 2022, 139 NSVT EVENTS WERE RECORDED, AND IT WAS QUESTIONED WHETHER THE PATIENT HAD EXPERIENCED SOME KIND OF TRAUMA TO THE DEVICE IMPLANT AREA DURING THAT TIME. TECHNICAL SERVICES RECOMMENDED TO CONTINUE MONITORING THE SITUATION EVERY THREE MONTHS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE RIGHT VENTRICULAR (RV) PACE IMPEDANCE MEASURED LESS THAN 200 OHMS AND NON-PHYSIOLOGIC NOISE WAS OBSERVED ON THE RV CHANNEL. TECHNICAL SERVICES RECOMMENDED CONTINUING ROUTINE MONITORING AND ALSO DISCUSSED ADDITIONAL LEAD MONITORING OPTIONS. THE RV LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499712 ENDOTAK RELIANCE SG IMPLANTABLE LEAD NVY BOSTON SCIENTIFIC CORPORATION 0292 114989

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Unknown