BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 3791035 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10511
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    February 10, 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
    MA, 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 THAT THE DEVICE SENT A MERLIN.NET TRANSMISSION SHOWING EPISODES OF NON-SUSTAINED LEAD NOISE DUE TO POST-PACED T-WAVE OVERSENSING. THE PATIENT WAS ASYMPTOMATIC. THE DEVICE WAS REPROGRAMMED, BUT EPISODES OF T-WAVE OVERSENSING PERSISTED. FURTHER REPROGRAMMING WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268603 QUADRA ASSURA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3365-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR