BEUDAMED
    FDA Adverse Event Death Summary report: N

    CPS QUARTET INNER-SUB-ACU 135MEAN 59CM

    MDR report key: 9177009 · Received October 10, 2019

    Report

    Report Number
    2017865-2019-14944
    Event Type
    Death
    Date Received
    October 10, 2019
    Date of Event
    October 1, 2019
    Report Date
    October 10, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    DQY
    UDI-DI
    05415067005717
    PMA / PMN Number
    K130252
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    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

    RELATED MANUFACTURER REFERENCE NUMBER:2017865-2019-14938, 2017865-2019-14940, 2017865-2019-14942, 2017865-2019-14943, 2017865-2019-14945. IT WAS REPORTED THAT THE PATIENT EXPIRED DURING AN IMPLANT PROCEDURE. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS DUE TO RESPIRATORY ISSUES DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970983 CPS QUARTET INNER-SUB-ACU 135MEAN 59CM CATHETER DQY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DS2N026-59 6021371 05415067005717

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death