BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 3923926 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14856
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 28, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    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. LEFT VENTRICULAR PORT OF DEVICE PLUGGED. EPICARDIAL LEAD IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD DISSECTED THE CORONARY SINUS DURING THE IMPLANT PROCEDURE. THE PATIENT FELT PAIN IN THE UPPER LEFT QUADRANT WITH THE DISSECTION. THE LEFT VENTRICULAR PORT OF THE DEVICE WAS PLUGGED AND THE PATIENT WAS DISCHARGED HOME. AN EPICARDIAL LEAD WAS SUCCESSFULLY IMPLANTED AT A LATER DATE AND THE PATIENT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402126 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1458Q/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other