BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST JUDE MEDICAL

    MDR report key: 82743 · Received April 3, 1997

    Report

    Report Number
    82743
    Event Type
    Death
    Date Received
    April 3, 1997
    Date of Event
    March 27, 1997
    Report Date
    April 3, 1997
    Manufacturer
    ST JUDE MEDICAL/CARDIAC ASSIST DIV.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIAC CATH AN IABP WAS INSERTED. POST CATH, THE BALLOON RUPTURED AND WAS REMOVED. A NEW IABP WAS NOT INSERTED. THE PT SUBSEQUENTLY DIED, HRS LATER. CAUSE OF DEATH IS NOT KNOWN. A SUPPLEMENTAL REPORT WILL BE FILED WHEN POST-MORTEM IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL Implant INTRA AORTIC BALLOON PUMP DSP ST JUDE MEDICAL/CARDIAC ASSIST DIV. 9 FR 6E6126

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death