BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 3925846 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15280
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    April 7, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE LEAD SHEATH CAUSED A SMALL DISSECTION TO THE CORONARY SINUS. THE LEAD WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404718 QUARTET PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1458Q/92 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other