BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 6128218 · Received November 27, 2016

    Report

    Report Number
    2938836-2016-14828
    Event Type
    Malfunction
    Date Received
    November 27, 2016
    Date of Event
    October 2, 2016
    Report Date
    October 10, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT PRESENTED VIA MERLIN.NET TRANSMISSION, NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING DUE TO POST-PACED T-WAVE OVERSENSING WAS OBSERVED ON THE VENTRICULAR CHANNEL. THE PATIENT DID NOT RECEIVE THERAPY DURING THE OVERSENSING. PROGRAMMING CHANGES WERE RECOMMENDED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778838 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3369-40Q S000021712

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR