BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA DR CRT-D

    MDR report key: 3943848 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13356
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 5, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THAT A MERLIN.NET TRANSMISSION SHOWED A RECURRENCE OF POST-PACED T-WAVE OVERSENSING. THE PATIENT WAS ASYMPTOMATIC. THE DEVICE WAS REPROGRAMMED AND REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MERLIN.NET TRANSMISSION SHOWED EPISODES OF NON-SUSTAINED LEAD NOISE DUE TO POST-PACED T-WAVE OVERSENSING. THE PATIENT WAS ASYMPTOMATIC. THE DEVICE WAS REPROGRAMMED AND REMAINS IMPLANTED. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421482 QUADRA ASSURA DR CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3365-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR