BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 388403 · Received April 9, 2002

    Report

    Report Number
    2182207-2002-00218
    Event Type
    Malfunction
    Date Received
    April 9, 2002
    Date of Event
    March 6, 2002
    Report Date
    March 13, 2002
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER RECEIVED PUMP FOR ANALYSIS AND NO CATHETER RETURNED. NO INFORMATION RECEIVED. FOLLOW UP WITH FACILITY AND HEALTH CARE PROFESSIONAL REPORTS DIFFERED. ONE REPORTER STATED CATHETER FRACTURE AND OTHER STATED CATHETER WAS "OUT OF PLACE" AND THEREFORE NOT DELIVERING THERAPY. PUMP - NORMAL EOL AFTER 56 MONTHS. HEALTH CARE PROFESSIONAL STATED PATIENT HAD EXPERIENCED INCREASED SPASTICITY UNRELIEVED BY INCREASING RATE OF MEDICATION DELIVERY. HEALTH CARE PROFESSIONAL'S OPINION WAS CATHETER PROBLEM CAUSED EVENT. DEVICE SYSTEM EXPLANTED AND PATIENT ELECTED TO NOT HAVE IT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA CATHETER LKK MEDTRONIC INC. 8703W L43747

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR PUMP: MODEL 861610, IMPLANT: 1997,| EXPLANT: 2002.