BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 644760 · Received November 4, 2005

    Report

    Report Number
    2182207-2005-01734
    Event Type
    Injury
    Date Received
    November 4, 2005
    Report Date
    October 20, 2005
    Manufacturer
    NEUROLOGICAL DIVISION, MEDTRONIC, INC
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THE PATIENT WAS RUNNING A FEVER OF 103-104 DEGREES. THREE WEEKS LATER, THE PATIENT PRESENTED WITH A FEVER OF 100.4 - 100.6 DEGREES AND A RASH ON HIS TRUNK, LEGS, AND PALMS OF HIS HANDS. THERE HAD BEEN NO CHANGE IN TONE OR SPASTICITY, HIS BLOOD PRESSURE WAS 90/60 WHICH WAS NORMAL FOR THIS PATIENT. THE PATIENT IS CURRENTLY ON BACLOFEN 500MCG/ML AT 126MCG/DAY. HE IS SUPPLEMENTED WITH BACLOFEN 20MCG EVERY 8 HOURS VIA A FEEDING TUBE. BLOOD WORK WAS DONE THAT SHOWED NO INFECTION. A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP LKK NEUROLOGICAL DIVISION, MEDTRONIC, INC 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Required Intervention