BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUARTET

    MDR report key: 4121387 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-07011
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    August 23, 2011
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD WOULD NOT ADVANCE THROUGH THE SHEATH. ANOTHER ATTEMPT WAS MADE BY USING THE SILICONE OIL, WHEN PEELING THE SHEATH THE LEAD MOVED AND THE CAPTURE THRESHOLDS INCREASED. THE LEAD WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33105 QUARTET PERMANETN PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, CRMD 1458Q/86

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR