BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE PLUS CRT-D

    MDR report key: 4092159 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-05009
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    February 15, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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: THE FIELD EVENT OF A SET SCREW ISSUE WAS CONFIRMED IN THE LABORATORY. ALL SET SCREWS HAD SILICONE IN THEIR HEX CAVITIES. THE SILICONE FOUND INSIDE THE SET SCREW HEX CAVITY PREVENTED FULL INSERTION OF THE TORQUE DRIVER INTO THE HEX CAVITY. THE CAUSE OF THE SET SCREW DAMAGE IS DUE TO SILICONE IN THE HEX CAVITIES.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING IMPLANT THE LEAD WOULD NOT EASILY GO INTO THE HEADER, RESULTING IN NOISE AND NO CAPTURE. THE LEAD ALSO BECAME STUCK IN THE HEADER. THIS DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23269 PROMOTE PLUS CRT-D NIK ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D CD3211-36

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR