BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE PLUS CRT-D, DF-4 CONNECTOR

    MDR report key: 3897852 · Received June 26, 2014

    Report

    Report Number
    2938836-2014-12465
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    April 7, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF THE INABILITY TO TIGHTEN THE SET SCREW WAS CONFIRMED IN THE LABORATORY. UPON RECEIPT, THE V DF-4 SET SCREW WAS ATTACHED TO THE TORQUE DRIVER. VISUAL INSPECTION IDENTIFIED SILICONE, SEPTUM MATERIAL IN THE SET SCREW HEX CAVITY. THIS MATERIAL PREVENTED FULL INSERTION OF THE TORQUE DRIVER INTO THE HEX CAVITY AND WAS THE CAUSE OF THE INABILITY OF THE SCREW TO TIGHTEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPTED IMPLANT, SETS CREW COULD NOT BE TIGHTENED WHEN CONNECTING THE RV LEAD TO THE DEVICE. SEVERAL HEX WRENCH WERE USED BUT ALL WERE UNSUCCESSFUL IN TIGHTENING THE SETSCREW. DEVICE WAS REPLACED. PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373631 PROMOTE PLUS CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1