BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURE QUADRA RF

    MDR report key: 3920643 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14256
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 17, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, IT WAS DIFFICULT TO INSERT AN ATRIAL LEAD INTO THE PULSE GENERATORS HEADER. AFTER MULTIPLE ATTEMPTS, THE LEAD WAS ABLE TO BE INSERTED INTO THE ATRIAL PORT. THE DEVICE WAS SUCCESSFULLY IMPLANTED AND THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398194 ALLURE QUADRA RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM3242 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR