BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

    MDR report key: 3220032 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04661
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    April 23, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NON-SUSTAINED LEAD NOISE EPISODES TRIGGERED BY INTERMITTENT POST-PACED T-WAVE OVERSENSING WERE OBSERVED. PROGRAMMING CHANGES WERE RECOMMENDED.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THAT THE DEVICE WAS REPROGRAMMED TO ADDRESS THE POST-PACED T-WAVE OVERSENSING. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THAT THE DEVICE CONTINUED TO EXHIBIT NSLN DUE TO POST-PACED T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE RECOMMENDED AND THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321287 QUADRA ASSURA CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3267-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1