BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURE QUADRA RF

    MDR report key: 3920654 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14257
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 7, 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
    TX, US
    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 THE PULSE GENERATOR WAS MISSING THE RIGHT VENTRICULAR PORTS SETSCREW UPON IMPLANT. THE DEVICE WAS NOT USED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397382 ALLURE QUADRA RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM3242 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR