BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD2257-40Q FORTIFY ASSURA DR ICD_IDE_US

    MDR report key: 13336865 · Received January 24, 2022

    Report

    Report Number
    2017865-2022-01755
    Event Type
    Malfunction
    Date Received
    January 24, 2022
    Date of Event
    January 7, 2022
    Report Date
    April 13, 2022
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVZ
    UDI-DI
    05414734505550
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED MANUFACTURER REPORT NUMBER ON TENDRIL SDX ATRIAL LEAD: 2017865-2020-17758.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ATRIAL OVERSENSING SEEN AS ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION EPISODES WERE OBSERVED IN REMOTE TRANSMISSIONS. PROGRAMMING RECOMMENDATIONS TO CONSIDER DECREASING THE ATRIAL SENSITIVITY WERE MADE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: 2017865-2020-17758. NEW INFORMATION RECEIVED NOTES THE ORIGINAL EVENT WAS DUE TO A KNOWN ATRIAL LEAD NOISE WITH PACING INHIBITION ISSUE OBSERVED IN 2020. THE ATRIAL LEAD WAS LEADING TO OVERSENSING SEEN ON ATRIAL FIBRILLATION AND ATRIAL TACHYCARDIA EPISODES. PROGRAMMING CHANGES WERE MADE. THERE HAD BEEN NO ISSUES SINCE THE PROGRAMING CHANGES WERE COMPLETED AT THE END OF JAN, 2022. THE PATIENT WAS DOING WELL AND HAD REPORTED NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614752 CD2257-40Q FORTIFY ASSURA DR ICD_IDE_US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NVZ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD2257-40Q 3862981 05414734505550

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male DURATA ACTIVE| TENDRIL SDX| TENDRIL SDX LEAD