BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 3923439 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14721
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 28, 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 Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR ROUTINE FOLLOW-UP. UPON INTERROGATION THE LEFT VENTRICULAR LEAD EXHIBITED HIGH IMPEDANCES. A FLUOROSCOPY WAS PERFORMED; IT DID NOT SHOW ANY DEFECT ON THE LEAD. THE DEVICE WAS REPROGRAMMED AND THE PATIENT WOULD BE MONITORED. THE PATIENT WAS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399332 QUICKFLEX MICRO LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1258T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1