BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 3923915 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14854
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 8, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT AND UPON POSITIONING THE LEAD, A SMALL DISSECTION WAS OBSERVED IN THE CORONARY SINUS. THE LEAD WAS NOT IMPLANTED, AND A NEW LEAD WAS USED. FOLLOWING THE EVENT, THE PATIENT WAS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401197 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1458Q/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention