BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D

    MDR report key: 3090168 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01226
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    November 28, 2012
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE INTERROGATION, AUTOMATIC MODE SWITCHING EPISODES ON THE VENTRICULAR CHANNEL WERE OBSERVED. REVIEW OF THE EPISODES NOTED SUSPECTED MYOPOTENTIALS. THE PATIENT WAS SCHEDULED FOR REGULAR FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191967 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3235-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1