BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUARTET LEAD DOUBLE BEND, 86 CM

    MDR report key: 17761120 · Received September 15, 2023

    Report

    Report Number
    2017865-2023-45143
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 28, 2023
    Report Date
    September 15, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    OJX
    UDI-DI
    05414734510189
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 201785-2023-45142. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR FOLLOW-UP. AN ELEVATED PACING IMPEDANCE AND NO CAPTURE WERE NOTED ON THE LEFT VENTRICULAR (LV) LEAD. THE DECISION WAS MADE TO TURN OFF THE LV LEAD. THE PATIENT WAS SYMPTOMATIC WITH THRESHOLD TESTING. UNKNOWN WHAT SYMPTOMS THE PATIENT WAS EXPERIENCING. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVER-SENSING OF NOISE. THE PATIENT WAS EXPERIENCING EPISODES OF NEAR SYNCOPE, DIZZINESS, AND LIGHTHEADED OVER THE LAST FEW MONTHS. PROGRAMMING CHANGES WERE MADE TO ADDRESS THE OVER-SENSING OF NOISE. THE PATIENT WAS IN STABLE CONDITION DURING INTERROGATION AND WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041098 QUARTET LEAD DOUBLE BEND, 86 CM Drug eluting permanent left ventricular (lv) pacemaker electrode OJX ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1457Q/86 S000022925 05414734510189

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female QUADRA ALLURE PACEMAKER.