BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA DDQP+

    MDR report key: 6325491 · Received February 13, 2017

    Report

    Report Number
    2938836-2017-14786
    Event Type
    Malfunction
    Date Received
    February 13, 2017
    Date of Event
    April 22, 2016
    Report Date
    January 16, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC WITH EPISODES OF NON-SUSTAINED VENTRICULAR OVERSENSING. TRANSMISSIONS WERE REVIEWED AND NOTED POST-PACED T-WAVE OVERSENSING WAS NOTED ON STORED EGM PREVIOUSLY. PROGRAMMING CHANGE WAS MADE. THE DEVICE LATER EXHIBITED ANOTHER EPISODE OF NVO AFTER PROGRAMMING CHANGE WAS MADE DUE TO POST-SENSED T-WAVE OVERSENSING. FURTHER PROGRAMMING CHANGES WERE MADE. PATIENT WILL CONTINUE TO BE MONITORED, AS THE OVERSENSING ISSUE IS STILL OCCURRING. PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109079 QUADRA ASSURA DDQP+ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3267-40Q 3983145

    Patients

    Seq Age Sex Outcome Treatment
    1