BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D, DF-4 CONNECTOR

    MDR report key: 4389542 · Received January 6, 2015

    Report

    Report Number
    2938836-2015-00310
    Event Type
    Injury
    Date Received
    January 6, 2015
    Date of Event
    November 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF A SET SCREW ANOMALY WAS CONFIRMED IN THE LABORATORY. VISUAL INSPECTION IDENTIFIED SEPTUM MATERIAL INSIDE OF THE LV IS-1 BI SET SCREW HEX CAVITY. IT IS BELIEVED THAT THIS MATERIAL PREVENTED FULL INSERTION OF THE TORQUE DRIVER IN THE SET SCREW HEX CAVITY.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, A SETSCREW ANOMALY WAS OBSERVED ON IS-1 PORT. THE DEVICE WAS LATER EXPLANTED AND REPLACED WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7618 UNIFY CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3235-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention