BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D

    MDR report key: 3101180 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-01991
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 29, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF CROSS-TALK COULD NOT BE REPRODUCED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND WAS FOUND TO BE NORMAL. DEVICE SENSING WAS NORMAL AT ALL TIMES DURING TESTING.

    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 THE DEVICE EXPERIENCED CROSSTALK ON THE VENTRICULAR CHANNEL. REPROGRAMMING THE DEVICE WAS RECOMMENDED, BUT THE CLINICIAN WAS WEARY OF THIS OPTION DUE TO THE PATIENTS PACER DEPENDENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202997 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention