BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 5701132 · Received June 6, 2016

    Report

    Report Number
    3007566237-2016-02204
    Event Type
    Injury
    Date Received
    June 6, 2016
    Date of Event
    January 1, 2016
    Report Date
    June 6, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER .

    Description of Event or Problem · 1

    STAMPACCHIA, G., MAZZOLENI, S., GERINI, A. EFFECTS OF SEVERE SPASTICITY TREATMENT WITH INTRATHECAL BACLOFEN IN MULTIPLE SCLEROSIS PATIENTS: LONG TERM FOLLOW-UP. NEUROREHABILITATION. 2016. DOI:10.3233/NRE-161329 SUMMARY: INTRATHECAL BACLOFEN IS AVAILABLE TO TREAT SEVERE GENERALIZED SPASTICITY IN MULTIPLE SCLEROSIS (MS) UNRESPONSIVE TO ORAL DRUG DELIVERY. THE AIMS OF THIS STUDY WERE TO INVESTIGATE THE EFFECTS AND THE DRUG DOSAGE OF INTRATHECAL BACLOFEN IN A SELECTED POPULATION OF MS PATIENTS, AFFECTED BY SEVERE SPASTICITY AT LONG TERM FOLLOW-UP. REPORTED EVENTS: COMPLICATIONS DUE TO THE PUMP AND CATHETER IMPLANTATION WERE OBSERVED IN ONLY ONE PATIENT; A CATHETER OBSTRUCTION PREVENTED THE ADEQUATE INTRATHECAL DRUG INFUSION AND THE EFFECT OBSERVED AFTER THE PREOPERATIVE. BACLOFEN BOLUS WAS NOT OBSERVED AFTER THE IMPLANTATION DESPITE THE PROGRESSIVE DOSE INCREASE. A NEW CATHETER AND PUMP REPLACEMENT WAS NECESSARY TO OBTAIN THE EXPECTED EFFECT OF INTRATHECAL BACLOFEN DELIVERY. THE CAUSE OF THIS UNIQUE COMPLICATION WAS A CATHETER MANUFACTURING DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355479 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention