BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA MP¿

    MDR report key: 9873297 · Received March 24, 2020

    Report

    Report Number
    2938836-2020-02153
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Date of Event
    March 4, 2020
    Report Date
    March 24, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    UDI-DI
    05414734508377
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOLLOWING DAY AFTER IMPLANT, FAR R-WAVE OVERSENSING WAS OBSERVED ON ELECTROGRAMS (EGMS). PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335037 QUADRA ASSURA MP¿ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3369-40Q 05414734508377

    Patients

    Seq Age Sex Outcome Treatment
    1