BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 3854663 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11556
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 15, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT FURTHER EPISODES OF POST-PACED T-WAVE OVERSENSING WERE OBSERVED. PATIENT WAS ASYMPTOMATIC. THE DEVICE WAS REPROGRAMMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC. THE DEVICE WAS POST-PACED T-WAVE OVERSENSING. PROGRAMMING CHANGES TO THE VENTRICULAR POST-PACED DECAY DELAY WERE MADE. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THAT DURING FOLLOW-UP, POST-PACED T-WAVE OVERSENSING WAS OBSERVED. PATIENT REMAINED ASYMPTOMATIC. PROGRAMMING CHANGES WERE RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330913 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 70 YR