BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 3910983 · Received July 2, 2014

    Report

    Report Number
    2938836-2014-13049
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    April 1, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT NON-SUSTAINED LEAD NOISE DUE TO POST-PACED T-WAVE OVERSENSING WAS OBSERVED VIA REMOTE TRANSMISSION. PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES WERE MADE.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT ANOTHER INSTANCE OF NON-SUSTAINED LEAD NOISE DUE TO POST-PACED T WAVE OVERSENSING WAS OBSERVED VIA REMOTE TRANSMISSION. PATIENT WAS ASYMPTOMATIC. ADDITIONAL OVERSENSING NEAR THE ATRIAL SENSED EVENTS WAS ALSO OBSERVED. PROGRAMMING CHANGES WERE RECOMMENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-PACED T WAVE OVERSENSING ON THE VENTRICULAR CHANNEL WAS OBSERVED VIA REMOTE TRANSMISSION. PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES WERE RECOMMENDED. THE DEVICE REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386494 QUADRA ASSURA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3265-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR