BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 13120273 · Received December 30, 2021

    Report

    Report Number
    2017865-2021-40482
    Event Type
    Injury
    Date Received
    December 30, 2021
    Report Date
    December 30, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    LU ZHENGDE, XUE YAN, LIN YINGZHONG, GAN JIANTING, YUAN JUN, QIN SHAOMING, HU CHANGXING 2021, 'LEFT VENTRICULAR QUADRIPOLAR LEAD FOR CARDIAC RESYNCHRONIZATION THERAPY IN DILATED CARDIOMYOPATHY: AN EFFECT OBSERVATION', JOURNAL OF MINIMALLY INVASIVE MEDICINE, VOL. 16, NO. 2, PP.169-173.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE JOURNAL OF MINIMALLY INVASIVE MEDICINE, THAT A CONTROL GROUP WITH QUICKFLEX ELECTRODES FOUND THE FOLLOWING EVENTS: 2 CASES OF LEAD DISLODGEMENT (16.7 %) WHICH LED TO REOPERATION; 4 CASES OF PHRENIC NERVE STIMULATION (33.3%), OF WHICH 3 CASES REQUIRED REOPERATION AND THE 4TH CASE WAS RESOLVED THROUGH REPROGRAMMING; 1 CASE HAD A HIGH CAPTURE THRESHOLD (8. 3%) THAT REQUIRED REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018474 QUICKFLEX MICRO LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1258T

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention