BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 360417 · Received October 30, 2001

    Report

    Report Number
    2182207-2001-00367
    Event Type
    Malfunction
    Date Received
    October 30, 2001
    Date of Event
    June 6, 2001
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT OF EVENT RECEIVED PER DEVICE RETURN FOR ANALYSIS STATING - "PT HAS HAD 'COMA' EPISODES - PUMP ROTOR STUDY AND DYE STUDY OK - DID SURGERY TO CHECK ON CONNECTOR/CATHETER." FOLLOW UP WITH HCP REVEALED THAT PT HAD, OVER A PERIOD OF A COUPLE OF MONTHS, EXPERIENCED POOR THERAPEUTIC RESULTS WITH SWINGS OF "SPASTIC WITHDRAWAL" AND SYMPTOMS OF "MALIGNANT HYPERTHERMIA" WITH PERIODS OF FLACCIDITY AND DIFFICULTY AROUSING PT. PT'S DOSE WAS UP TO 600 MCG PER DAY WITH POOR RESULTS. SURGICAL EXPLORATION WAS PERFORMED AND CATHETER BREAK DISCOVERED. HCP FEELS PT WAS GETTING "POSITIONAL" DOSES OF THE BACLOFEN AFTER DOSE INCREASES WERE STARTED. THE PT IS "DOING PERFECTLY" NOW ON LESS THAN 100 MCG PER DAY SINCE THE CATHETER/CONNECTOR PROBLEM WAS CORRECTED. PUMP AND CATHETER REMAIN IMPLANTED - REPLACEMENT WAS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48509 INDURA CATHETER LKK MEDTRONIC INC. 8709 L80323

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization SYNCHROMED EL MODEL 8627L18 IMPLANTED/2000 REMAINS| IMPLANTED.