BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D

    MDR report key: 3101244 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-02036
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 27, 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
    IL
    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 DEVICE WAS EXPERIENCING NON-SUSTAINED LEAD NOISE. INVESTIGATION SHOWED THAT THE NOISE WAS DUE TO T-WAVE OVERSENSING WHEN THE PATIENTS HEART RATE ENTERED PERIODS OF POTENTIAL TACHYCARDIA. NO ADVERSE EVENTS WERE REPORTED. DEVICE WAS REPROGRAMMED AND REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204253 QUADRA ASSURA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3265-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR