BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUARTET

    MDR report key: 4191862 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04796
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    March 30, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO 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. ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE LEFT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE, AND INSULATION ANOMALY, AND DISLODGED. THE LEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29054 QUARTET PERMANENT PACEMAKER ELECTRODE, DTB DTB ST. JUDE MEDICAL, INC., CRMD 1458Q/75

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR