BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSAID IMPLANTABLE INFUSION PUMP

    MDR report key: 104464 · Received July 10, 1997

    Report

    Report Number
    1219454-1997-00312
    Event Type
    Injury
    Date Received
    July 10, 1997
    Date of Event
    September 17, 1996
    Report Date
    June 17, 1997
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    MDY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED ON 9/10/1996, FOR ARTERIAL INFUSION OF FUDR FOR TREATMENT OF CANCER. ON 6/17/1997, THE FACILITY'S STUDY COORDINATOR INFORMED THE MFR'S (MFR) CLINICAL AFFAIRS DEPARTMENT VIA A THERAPY COMPLICATIONS REPORT THAT DURING A MONITORING VISIT IT WAS NOTED BY A MFR REPRESENTATIVE THAT THE POSTOPERATIVE PERFUSION SCAN DONE ON 9/17/96, SHOWED A SMALL AREA OF ACTIVITY OUTSIDE OF THE LIVER SUGGESTING EXTRAHEPATIC PERFUSION. THE REPORT STATED THE FOLLOWING: "THE TCMAA HEPATIC PERFUSION STUDY SHOWED EVIDENCE OF A SMALL AMOUNT OF ACTIVITY OUTSIDE THE LIVER. IT WAS FELT AT THAT TIME THAT THE FINDING WAS NOT CLINICALLY SIGINIFICANT. THE PT WAS STARTED ON CHEMOTHERAPY AND MONITORED CLINICALLY. FURTHER WORKUP OF THE POSSIBLE MISPERFUSION WAS NOT MERITED. " NO FURTHER DETAILS WERE PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSAID IMPLANTABLE INFUSION PUMP Implant IMPLANTABLE INFUSION PUMP MDY STRATO/INFUSAID, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention