BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 5692017 · Received June 1, 2016

    Report

    Report Number
    3007566237-2016-02162
    Event Type
    Injury
    Date Received
    June 1, 2016
    Date of Event
    February 21, 2016
    Report Date
    June 1, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. CONCOMITANT PRODUCT: PRODUCT ID: NEU_UNKNOWN_PUMP, PRODUCT TYPE: PUMP.

    Description of Event or Problem · 1

    BONOUVRIE, L., BECHER, J., SOUDANT, D., BUIZER, A., VAN OUWERKERK, W., VLES, G., VERMEULEN, R.J. THE EFFECT OF INTRATHECAL BACLOFEN TREATMENT ON ACTIVITIES OF DAILY LIFE IN CHILDREN AND YOUNG ADULTS WITH CEREBRAL PALSY AND PROGRESSIVE NEUROLOGICAL DISORDERS. EUROPEAN JOURNAL OF PAEDIATRIC NEUROLOGY. 2016. 1090:MAR 3. DOI: 10.1016/J.EJPN.2016.02.013 SUMMARY: INTRATHECAL BACLOFEN (ITB) TREATMENT IS APPLIED IN PATIENTS WITH SPASTIC CEREBRAL PALSY (SCP), DYSTONIC CEREBRAL PALSY (DCP) AND PROGRESSIVE NEUROLOGICAL DISEASE (PND). OUR AIM WAS TO INVESTIGATE WHETHER ITB TREATMENT HAS A DIFFERENT EFFECT ON ACTIVITIES OF DAILY LIFE (ADL) IN THESE GROUPS. REPORTED EVENTS: ONE PUMP WAS EXPLANTED AFTER NINE YEARS DUE TO INSUFFICIENT EFFECT OF ITB TREATMENT. SOME OF THE PATIENTS REPORTED AN INCREASE IN SCOLIOSIS RESULTING IN MORE DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346872 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention