BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 1288088 · Received January 13, 2009

    Report

    Report Number
    MW5009607
    Event Type
    Malfunction
    Date Received
    January 13, 2009
    Date of Event
    September 25, 2007
    Report Date
    January 13, 2009
    Manufacturer
    MEDTRONIC
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD MULTIPLE PROBLEMS WITH HIS INTRATHECAL CATHETER INSERTED IN 2007 AND REQUIRED MULTIPLE REVISIONS. HE ENDED UP WITH MENINGITIS THE FOLLOWING MONTH, AND THE FIRST RECALLED DEVICE WAS REMOVED. HE WAS ON IV ANTIBIOTICS FOR 2 MONTHS, AND ANOTHER DEVICE WAS IMPLANTED TWO MONTHS LATER. THIS TOO IS A RECALLED DEVICE. DEVICE NOT RECALLED UNTIL 2008. HE STILL HAS THE RECALLED DEVICE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INDURA INTRATHECAL CATHETER LKK MEDTRONIC N120274001

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR