BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

    MDR report key: 3101220 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-02053
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    February 8, 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
    WI
    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 ATRIAL NOISE REVERSION EPISODES WERE OBSERVED. CUSTOM PROGRAMMING WAS RECOMMENDED. THE PHYSICIAN CHOSE TO NOT DO CUSTOM PROGRAMMING AND TO CONTINUE TO MONITOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203053 QUADRA ASSURA CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3265-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR