BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACTICATH QUARTZ

    MDR report key: 5517470 · Received March 22, 2016

    Report

    Report Number
    5517470
    Event Type
    Malfunction
    Date Received
    March 22, 2016
    Date of Event
    February 10, 2016
    Report Date
    February 12, 2016
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CATHETER WAS REMOVED FROM PACKAGING AND PREPPED ACCORDING TO PROTOCOL. IT WAS INSERTED INTO THE PATIENT, BUT ELECTRODE #2 WAS PULLING (NOT WORKING) AND NO ELECTROGRAM COULD BE SEEN ON THE SCREEN AT THAT ELECTRODE EITHER. WE TRIED TO CHANGE OUT THE CABLES BUT THAT DIDN'T WORK, SO THE CATHETER WAS EXCHANGED FOR A NEW ONE (LOT FOR THE NEW ONE: 5202912)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173395 TACTICATH QUARTZ CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION LPB ST. JUDE MEDICAL PN-0040 65 5274927

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR NO