BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

    MDR report key: 3854673 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11523
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 1, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHEN THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC AFTER EXPERIENCING VIBRATORY ALERT FOR NON-SUSTAINED LEAD NOISE DUE TO POST PACED T-WAVE OVERSENSING. POST PACED T-WAVE OVERSENSING WAS OBSERVED ON THE STORED EGM. PROGRAMMING CHANGES WERE MADE AND NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330828 QUADRA ASSURA CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3265-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR