BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA CRT-D

    MDR report key: 3090068 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01239
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 4, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 THE ASYMPTOMATIC PATIENT PRESENTED FOR FOLLOW UP. REVIEW OF THE STORED EGMS REVEALED POST-PACED T-WAVE OVERSENSING. DEVICE WAS REPROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191004 UNIFY ASSURA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR