BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 3545352 · Received December 31, 2013

    Report

    Report Number
    3007566237-2013-04219
    Event Type
    Injury
    Date Received
    December 31, 2013
    Report Date
    December 2, 2013
    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

    THE PROVIDED AGE WAS THE AVERAGE FOR ALL PATIENTS. THE PROVIDED SEX WAS THE MAJORITY AMONG ALL PATIENTS. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    MAEYAERT, J., BUCHSER, E., VAN BUYTEN, J. P., RAINOV, N. G., BECKER, R. PATIENT-CONTROLLED ANALGESIA IN INTRATHECAL THERAPY FOR CHRONIC PAIN: SAFETY AND EFFECTIVE OPERATION OF THE MODEL 8831 PERSONAL THERAPY MANAGER WITH A PRE-IMPLANTED SYNCHROMED INFUSION SYSTEM. NEUROMODULATION : JOURNAL OF THE INTERNATIONAL NEUROMODULATION SOCIETY. 2003;6(3):133-141. SUMMARY: THE MODEL 8831 PERSONAL THERAPY MANAGER (PTM) OFFERS A PATIENT-CONTROLLED ANALGESIA (PCA) OPTION FOR THE SYNCHROMED INFUSION SYSTEM (MEDTRONIC INC., MINNEAPOLIS, MN). THE SAFETY AND EFFECTIVE OPERATION OF THE PTM ACTIVATOR WAS EVALUATED IN 45 PATIENTS IN FIVE EUROPEAN CENTERS RECEIVING INTRATHECAL DRUG INFUSION FOR THE TREATMENT OF CHRONIC PAIN VIA A SYNCHROMED PUMP. THE TOTAL VOLUME OF DRUG DELIVERED INTRATHECALLY OVER A FOUR-WEEK FOLLOW-UP PERIOD WAS CALCULATED. ADVERSE EVENTS WERE RECORDED AND PAIN LEVELS WERE MEASURED VIA THE VISUAL ANALOG PAIN SCALE (VAS), BRIEF PAIN INVENTORY, AND SF-12 QUALITY OF LIFE SCORES. PATIENT SATISFACTION WITH THE DEVICE AND ITS INSTRUCTION MANUAL WAS ALSO ASSESSED BY QUESTIONNAIRE. THE EXPECTED AND CALCULATED INTRATHECAL DRUG VOLUMES (AND THEREFORE DRUG DOSES) WERE THE SAME, DEMONSTRATING THAT THE DEVICE WORKED AS INTENDED. THERE WERE NO DEVICE-RELATED SERIOUS ADVERSE EVENTS. OVERALL, 96% OF PATIENTS WERE SATISFIED WITH THE ACTIVATOR. PATIENTS APPRECIATED BEING ABLE TO CONTROL THEIR PAIN AND CONSIDERED THE DEVICE AND ITS INSTRUCTIONS EASY TO USE. THE PTM WAS SHOWN TO BE SAFE AND FUNCTIONING PROPERLY IN THE INTRATHECAL TREATMENT OF PAIN. THE SUCCESSFUL ADDITION OF A PCA FUNCTION TO THE SYNCHROMED SYSTEM MAY CREATE A NEW STANDARD IN INTRATHECAL PAIN THERAPY. REPORTED EVENTS: ONE PATIENT WAS HOSPITALIZED DUE TO HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682807 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8617

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Hospitalization