BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR

    MDR report key: 4091421 · Received January 14, 2014

    Report

    Report Number
    2017865-2014-07787
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Date of Event
    November 5, 2012
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, 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. EVAL DESCRIPTION INCLUDED. ANALYSIS CONFIRMED SETSCREW ISSUE. EXCESS MED-A WAS NOTED BETWEEN THE A-TIP AND V-TIP SEPTUMS THAT FUSED THE TWO TOGETHER. THE INNER A-TIP SEPTUM WAS DAMAGED AND THE SETSCREW INSET NOTED SEPTUM MATERIAL CLOGGING INSET. THE A-TIP SETSCREW INSET WAS STRIPPED ABOUT 60% MAKING IT DIFFICULT TO TIGHTEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE PULSE GENERATOR EXHIBITED A SET SCREW ISSUE. THE DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34733 ACCENT DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION PM2110

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR