BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1344911 · Received March 16, 2009

    Report

    Report Number
    2182207-2009-01858
    Event Type
    Injury
    Date Received
    March 16, 2009
    Date of Event
    August 1, 2008
    Report Date
    February 17, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: UETA T. (INTRATHECAL BACLOFEN FOR SEVERE SPASTICITY]. BRAIN NERVE. 2008-60(12): 1415-1420. SUMMARY: THIS STUDY EVALUATED 40 PTS FROM 2002 - 2008 FOR USE OF INTRATHECAL BACLOFEN FOR THE CONTROL OF SPASTICITY. DURING SCREENING TRIAL WITH INTRATHECAL BACLOFEN, PT EXPERIENCED MARKED DECREASE IN LOWER EXTREMITY SPASTICITY. EFFECTS WERE EXPERIENCED FROM APPROX 2 - 12 HOURS FOLLOWING LUMBAR PUNCTURE. THE EFFECTS GRADUALLY DIMINISHED AND DISAPPEARED COMPLETELY BETWEEN 24 - 36 HOURS AFTER ADMINISTRATION. SOME COMPLICATIONS WERE MILD DECREASE IN BLOOD PRESSURE AND CEPHALALGIA - NOT REQUIRING TREATMENT. AFTER PUMP IMPLANTATION PT EXPERIENCED A DISAPPEARANCE OF BINDING SENSATION IN TRUNCAL AREA; EASIER BREATHING; BETTER SLEEP; NIGHTTIME RESTRAINING BANDS REMOVED; IMPROVEMENTS IN ANTEFLEXION; IMPROVEMENTS IN PRESSURE SORES AND GENERAL IMPROVEMENT IN MOBILITY. AN INFECTION IN THE INCISION AREA DID NOT HEAL AND ALL EQUIPMENT, INCLUDING THE PUMP AND CATHETER, HAD TO BE REMOVED. THE PT STRONGLY DESIRED THAT THE PUMP BE RE-IMPLANTED, IMPLANTATION WAS PERFORMED ON THE OPPOSITE SIDE AND BACLOFEN ADMINISTRATION WAS RE-STARTED. FOUR YEARS HAVE SINCE PASSED, AND THE SPASTICITY IS BEING CONTROLLED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK MEDTRONIC NEUROMODULATION 8627 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention CATHETER: MODEL CATHETER| IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER| EXPLANTED:| EXPLANTED:| IMPLANTED: