BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 6052547 · Received October 24, 2016

    Report

    Report Number
    2938836-2016-13257
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 9, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MERLIN.NET TRANSMISSION SHOWED POST PACED T WAVE OVERSENSING. REPROGRAMMING WAS RECOMMENDED. THE PATIENT CONDITION WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703772 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3371-40QC A000018394

    Patients

    Seq Age Sex Outcome Treatment
    1