BEUDAMED
    FDA Adverse Event Summary report: N

    PROGRAMMABLE DRUG DELIVERY DEVICES

    MDR report key: 926831 · Received October 11, 2007

    Report

    Report Number
    2182207-2007-03199
    Date Received
    October 11, 2007
    Report Date
    July 20, 2006
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP IS IN PROCESS TO ESTABLISH SPECIFIC EVENT DETAILS AND ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN AVAILABLE. THE CATHETER MANUFACTURER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: GUILLAUME D, VAN HAVENBERGH A, ET AL. "A CLINICAL STUDY OF INTRATHECAL BACLOFEN USING A PROGRAMMABLE PUMP FOR INTRACTABLE SPASTICITY." ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION. 2005; 86(11): 2165-71. THE ARTICLE DESCRIBES A STUDY OF 129 ENROLLED PATIENTS BEING TREATED WITH ITB THERAPY FOR INTRACTABLE SPASTICITY. FORTY THREE PERCENT OF PATIENTS EXPERIENCED SOME TYPE OF ADVERSE EVENT. FIVE PATIENTS EXPIRED DURING THE STUDY. THE CAUSE OF DEATH OF ALL EXPIRED PATIENTS WAS REPORTED TO BE UNRELATED TO ITB THERAPY. REPORTABLE EVENTS: CATHETER (N=12) PREIMPLANT 11 PATIENTS REPORTED 12 ADVERSE EVENTS RELATED TO THE CATHETER DELIVERING THE TEST DOSE OF BACLOFEN. TWENTY PERCENT OF THE PATIENTS (N=26) EXPERIENCED (UNDEFINED) ADVERSE EVENTS THAT WERE PATIENT RELATED. PUMP (N=8) EIGHT PATIENTS (N=8) EXPERIENCED A SURGERY RELATED ADVERSE EVENTS: SPINAL HEADACHE (N=1), MENINGITIS (N=1), PAIN IN LEG (N=1), INCONTINENCE (N=2), POCKET WOUND INFECTION (N=3). CATHETER (N=9) FIVE PATIENTS EXPERIENCED CATHETER RELATED EVENTS: DISLODGEMENT (N=4), CATHETER KINK (N=3), OCCLUSION (N=1), UNDER INFUSION (N=1), SPINAL HEADACHE (N=1). THE CATHETER MANUFACTURER WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMABLE DRUG DELIVERY DEVICES LKK MEDTRONIC NEUROMODULATION UNKNOWN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR