BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 6063666 · Received October 28, 2016

    Report

    Report Number
    2938836-2016-13486
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    September 5, 2016
    Report Date
    September 28, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THROUGH REMOTE TRANSMISSION, THE DEVICE EXHIBITED MYOPOTENTIAL OVERSENSING SIGNALS RESULTING IN INHIBITION OF PACING. THE PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES AND FURTHER TESTING WERE RECOMMENDED. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED WITH REGULAR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715999 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3369-40Q A000025198

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR