BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA DDQP+

    MDR report key: 4893801 · Received July 7, 2015

    Report

    Report Number
    3010215456-2015-27834
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    May 29, 2015
    Report Date
    May 29, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC. (CRM-KISTA)
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-PACED T-WAVE OVERSENSING WAS OBSERVED ON A REMOTE TRANSMISSION. THE DEVICE WAS REPROGRAMMED. NO ADVERSE CONSEQUENCES FOR THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440806 QUADRA ASSURA DDQP+ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC. (CRM-KISTA) CD3267-40Q 3892850

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention