BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 3923916 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14855
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 29, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DISSECTION OF CORONARY SINUS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF THE LEFT VENTRICULAR LEAD, A SMALL DISSECTION OF CORONARY SINUS WAS CONFIRMED WITH CONTRAST FLUID. THE LEAD WAS IMPLANTED IN THE POSTERO-LATERAL VEIN OF CORONARY SINUS. THE CONDITION OF THE PATIENT WAS GOOD BOTH DURING AND AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401344 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1458Q/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other