BEUDAMED
    FDA Adverse Event Other Summary report: N

    ST JUDE MEDICAL

    MDR report key: 12282 · Received January 31, 1994

    Report

    Report Number
    12282
    Event Type
    Other
    Date Received
    January 31, 1994
    Date of Event
    January 20, 1994
    Report Date
    January 24, 1994
    Manufacturer
    CARDIAC ASSIST DIV. ST. JUDE MEDICAL
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 1/20/94 AT 1210 THE INTRA-AORTIC BALLOON WAS INSERTED VIA RIGHT FEMORAL PAST CABG PROCEDURE. ON 1/20/94 AT 1730 IAB WAS REMOVED SECONDARY TO RUPTURE. BP STABLE. NO FURTHER PROCEDURES REQUIRED. CO'S PUMP IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL INTRA-AORTIC BALLOON DSP CARDIAC ASSIST DIV. ST. JUDE MEDICAL 9 FR 40 CC 503042

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other