BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOMED

    MDR report key: 1021095 · Received March 27, 2008

    Report

    Report Number
    2182207-2008-01603
    Event Type
    Injury
    Date Received
    March 27, 2008
    Report Date
    May 17, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    LITERATURE. ROYBAL J ET AL. "PUMP REMOVAL IN INFECTED PTS WITH HEPATIC CHEMOTHERAPY PUMPS: WHEN IS IT NECESSARY?" THE AMERICAN SURGEON. OCT 2006. 72: 880-884. TWO PTS REQUIRED REMOVAL OF THE PUMP DUE TO THE PUMP POCKET BEING INFECTED. PROD THOUGHT TO BE MEDTRONIC ISOMED PUMP, BUT COULD NOT CONFIRM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOMED LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CATHETER MODEL CATHETER LOT# UNK| IMPLANTED| EXPLANTED