BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 3923442 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14724
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 21, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE LEAD WAS RETURNED IN THREE PIECES. AN ABRASION WAS NOTED AT 2.7 CM TO 3.7 CM FROM THE CONNECTOR PIN. THE RE CABLE WAS NOTED TO BE FRACTURED DUE TO FATIGUE. THIS LIKELY CONTRIBUTED TO THE REPORTED ELECTRICAL ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCE AND AN INCREASE IN CAPTURE THRESHOLD WAS OBSERVED ON THE LEFT VENTRICULAR LEAD. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399333 QUICKFLEX MICRO LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1258T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention