BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 4192217 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04312
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    September 8, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. EVALUATION DESCRIPTION: FINAL ANALYSIS CONFIRMED THE COMPLAINT. IT REVEALED THAT THERE WAS AN AMOUNT OF MEDICAL ADHESIVE IN THE SET SCREW THAT PREVENTED THE WRENCH FROM SETTING PROPERLY IN THE SCREW. THIS CAUSED THE SCREW TO STRIP AS TORQUE WAS APPLIED. PREVENTING THE SET SCREW FROM TIGHTENING PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT, THE PULSE GENERATOR HAD UNACCEPTABLE IMPEDANCE AND THRESHOLD. THE DEVICE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27514 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2210

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR