BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 3923949 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14872
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 3, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCE VALUES WERE OBSERVED ON THE LEFT VENTRICULAR LEAD DURING AN UNRELATED ELECTIVE SPINAL NERVE ABLATION PROCEDURE FOR CHRONIC PAIN MANAGEMENT. A REVIEW OF DEVICE PRINTOUTS SHOWED THAT IMPEDANCE HAD BEEN HIGH PRIOR TO THE PROCEDURE. THE LEFT VENTRICULAR PACING CONFIGURATION WAS ALTERED AND ELECTRICAL VALUES WERE ACCEPTABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401422 QUICKFLEX MICRO LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1258T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR