BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA MP

    MDR report key: 11496872 · Received March 16, 2021

    Report

    Report Number
    2017865-2021-11860
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 24, 2021
    Report Date
    March 16, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. 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. SERIAL NUMBER, MANUFACTURING DATE, EXPIRATION DATE, UDI, IMPLANT DATE, PHYSICAL MANUFACTURING SITE, PATIENT NAME, DATE OF BIRTH, GENDER, ARE UNKNOWN SINCE THE SERIAL NUMBER WAS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED MULTIPLE FALSE ATRIAL FIBRILLATION EPISODES DUE TO FAR R OVERSENSING. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394800 QUADRA ASSURA MP IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3369-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1