BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 6040494 · Received October 19, 2016

    Report

    Report Number
    2938836-2016-12914
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 23, 2016
    Report Date
    September 23, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING DUE TO POST-PACED T-WAVE OVERSENSING WAS OBSERVED VIA A MERLIN AT HOME TRANSMISSION. PROGRAMMING CHANGES WERE MADE AND THE ISSUE WAS RESOLVED. THE PATIENT'S CONDITION PRIOR, DURING AND AFTER THIS INCIDENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693220 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3371-40QC A000014733

    Patients

    Seq Age Sex Outcome Treatment
    1