BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROGRAMMABLE DRUG DELIVERY DEVICES

    MDR report key: 921652 · Received September 21, 2007

    Report

    Report Number
    2182207-2007-03032
    Event Type
    Other
    Date Received
    September 21, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: SCHUELE SU, KELLINGHAUS C, ET. AL. "INCIDENCE OF SEIZURES IN PATIENTS WITH MULTIPLE SCLEROSIS TREATED WITH INTRATHECAL BACLOFEN." NEUROLOGY 2005; 64(6): 1086-7. THE ARTICLE DESCRIBES A STUDY OF 99 MS PATIENTS BEING TREATED WITH INTRATHECAL BACLOFEN FOR SPASTICITY USING IMPLANTABLE INFUSION PUMPS AND CATHETERS. REPORTABLE EVENTS: THE PROGRAMMER (N=1) - ONE PATIENT EXPERIENCED NONCONVULSIVE STATUS EPILEPTICUS (NCSE) IMMEDIATELY AFTER THE INITIATION OF ITB THERAPY. EVALUATION OF THE PUMP RESERVOIR REVEALED AND ACCIDENTAL OVERDOSE OF 10 FOLD (2,050 UG THE PROGRAMMED BOLUS). VIDEO-EEG DEMONSTRATED FREQUENT SUB-CLINICAL FOCAL SEIZURES. THE PUMP (N=1) - ONE PATIENT DEVELOPED NCSE IN THE SETTING OF SEPSIS 3 MONTHS AFTER PUMP IMPLANTATION. VIDEO-EEG DEMONSTRATED FREQUENT SUBCLINICAL FOCAL SEIZURES. THE PUMP (N=1) ONE PATIENT DEVELOPED RECURRENT RIGHT FOCAL MOTOR STATUS EPILEPTICUS 2.5 YEARS AFTER ITB THERAPY WAS INITIATED. THE EPILEPTIC EVENTS REPEATEDLY OCCURRED IN THE SETTING OF FEBRILE URINARY TRACT INFECTIONS AND RESOLVED WITH ANTIBIOTIC AND ANTIEPILEPTIC THERAPY WHILE THE ITB TREATMENT WAS CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMABLE DRUG DELIVERY DEVICES LKK MEDTRONIC NEUROMODULATION N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention