BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 633280 · Received August 30, 2005

    Report

    Report Number
    2182207-2005-01347
    Event Type
    Injury
    Date Received
    August 30, 2005
    Date of Event
    July 31, 2005
    Report Date
    August 15, 2005
    Manufacturer
    NEUROLOGICAL DIVISION, MEDTRONIC, INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THAT THE PT WAS ALSO EXPERIENCING INCREASED IRRITABILITY, SPASTICITY, AND DYSTONIA. XRAYS WERE NEGATIVE. PT WAS ADMITTED TO THE HOSP AND SUBSEQUENTLY DISCHARGED. XRAYS TAKEN AGAIN ON 08/2005 WERE NOTED TO BE NEGATIVE. THE PT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IN 2005 THE PT DEVELOPED SIGNS OF "BACLOFEN WITHDRAWAL; ITCHY, INCREASED TONE AND LOW FEVER". THE PT WAS SEEN IN THE HCP'S OFFICE IN 08/2005 AT WHICH TIME A CATHETER DYE STUDY WAS PERFORMED AND WAS FOUND TO BE NEGATIVE. THE PT WAS GIVEN A 100 MCG BOLUS WITH NO CHANGE IN SYMPTOMS. A BOLUS OF 175 MCG WAS GIVEN WITH A SLIGHT DECREASE IN THE WITHDRAWAL SYMPTOMS. THE PT'S DAILY DOSE WAS THEN INCREASED FROM 350 MCG TO 450 MCG/DAY. "THE PT RETURNED HOME WITHOUT SIGNS OF WITHDRAWAL". FIVE DAYS LATER THE PT AGAIN "DEVELOPED SIGNS OF BACLOFEN WITHDRAWAL. THE PT WAS SEEN IN THE HCP'S OFFICE TWO DAYS LATER AND WAS SCHEDULED FOR SURGERY. THE CATHETER WAS NOTED TO BE "NORMAL AND INTACT DURING SURGICAL OBSERVATION". THE PUMP AND CATHETER WERE REPLACED AND THE PT WAS PUT BACK ON A DAILY DOSE OF 450 MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP LKK NEUROLOGICAL DIVISION, MEDTRONIC, INC. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization| R