BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D

    MDR report key: 4153506 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16403
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 29, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN AN ASYMPTOMATIC PATIENT PRESENTED A MERLIN TRANSMISSION, NON-SUSTAINED LEAD NOISE DUE TO POST-PACED T-WAVE OVERSENSING WAS OBSERVED. REPROGRAMMING CHANGES WERE MADE. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630478 QUADRA ASSURA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3265-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR