BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D

    MDR report key: 3220122 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04529
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    April 23, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED FIELD EVENT OF BEING UNABLE TO INSERT THE LEAD WAS CONFIRMED IN THE LABORATORY. THE LV LEAD COULD NOT BE FULLY INSERTED INTO THE HEADER. ANALYSIS OBSERVED THAT THE SET SCREW WAS PROTRUDED INTO THE LEAD BORE WHICH PREVENTED THE LEAD FROM BEING INSERTED. AFTER THE SET SCREW WAS BACKED OUT, THE LEAD INSERTED PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGE OUT, THE CHRONIC LEAD WOULD NOT INSERT INTO THE PORT OF THE NEW DEVICE. THE DEVICE WAS NOT IMPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320999 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR