BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 6152127 · Received December 7, 2016

    Report

    Report Number
    2938836-2016-15748
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    October 21, 2016
    Report Date
    October 21, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT FOR NON SUSTAINED RIGHT VENTRICULAR OVERSENSING DUE TO MYOPOTENTIAL OVERSENSING WAS OBSERVED VIA A MERLIN.NET TRANSMISSION. REPROGRAMMING CHANGES WERE RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801532 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3369-40Q A000022082

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR