BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1062112 · Received June 18, 2008

    Report

    Report Number
    2182207-2008-03343
    Event Type
    Injury
    Date Received
    June 18, 2008
    Report Date
    May 20, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: KOULOUSAKIS A. INTRATHECAL ANTISPASTIC DRUG APPLICATION WITH IMPLANTABLE PUMPS: RESULTS OF A 10 YEAR FOLLOW-UP STUDY. ACTA NEUROCHIR SUPPL 2007; 97 (PT. 1): 181-184. SINCE 1986, MORE THAN 300 PATIENTS RECEIVED AN INTRATHECAL BACLOFEN (ITB) PUMP FOR THE TREATMENT OF SEVERE SPASTICITY. CHRONIC ITB ADMINISTRATION IS A SAFE AND EFFECTIVE METHOD, WHICH SIGNIFICANTLY DECREASES PATHOLOGICALLY EXAGGERATED MUSCLE TONE AND IMPROVES THE QUALITY OF LIFE IN MOST PATIENTS. IN OUR SERIES WITH A FOLLOW-UP PERIOD OF 10 YEARS, THE ITB DOSE REMAINED CONSTANT AND NO DEVELOPMENT OF TOLERANCE WAS OBSERVED IN MOST PATIENTS. REPORTABLE EVENT: ONE PATIENT EXPERIENCED FORMATION OF A GRANULOMA AT THE CATHETER TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R PROGRAMMER MODEL UNK N=1| IMPLANTABLE INFUSION PUMP MODEL UNK N=1