BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D QUAD RF HV

    MDR report key: 4844893 · Received June 15, 2015

    Report

    Report Number
    2938836-2015-26896
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 13, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P970013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THROUGH REMOTE TRANSMISSION, THE DEVICE EXHIBITED POST-PACED T-WAVE OVERSENSING ON A STORED EGM. THE PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES WERE RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388237 QUADRA ASSURA CRT-D QUAD RF HV IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3365-40Q 4626209

    Patients

    Seq Age Sex Outcome Treatment
    1