BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

    MDR report key: 3101284 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-02071
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    February 25, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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

    NEW INFORMATION RECEIVED NOTES THAT DURING A SUBSEQUENT FOLLOW-UP, MORE NON-SUSTAINED LEAD NOISE EPISODES WERE OBSERVED. REPROGRAMMING THE DEVICE WAS PERFORMED. NO CONSEQUENCES TO THE PATIENT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE FOLLOW UP, A NON-SUSTAINED RV LEAD NOISE EPISODE WAS NOTED. T-WAVE OVERSENSING WAS OBSERVED. REPROGRAMMING WAS PERFORMED TO ADJUST DECAY DELAY AND THRESHOLD START.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THAT DURING FOLLOW-UP, NON-SUSTAINED LEAD NOISE DUE TO POST PACED T-WAVE OVERSENSING CONTINUED TO BE OBSERVED. THE PATIENT IS STABLE AND THE DEVICE WAS REPROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203444 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 69 YR