BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 645984 · Received November 9, 2005

    Report

    Report Number
    2182207-2005-01755
    Event Type
    Injury
    Date Received
    November 9, 2005
    Report Date
    November 1, 2005
    Manufacturer
    NEUROLOGICAL DIC, MEDTRONIC, INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE LAST REFILL WAS IN 2005. THE REFILL MAY HAVE BEEN COMPLICATED BY A POSSIBLE POCKET FILL DUE TO THE PT EXPERIENCING A SEIZURE-LIKE EPISODE AT THE TIME PUMP WAS ACCESSED." THE HCP WAS ATTEMPTING TO FILL THE PUMP WITH 20 CCS WHEN "SHE THOUGHT THE NEEDLE WAS JARED AND MAY HAVE BEEN PULLED OUT OF THE RESERVOIR FILL PORT." THE HCP DID NOT UPDATE THE PUMP WITH THE NEW RESERVOIR VOLUME AT THE TIME OF THE REFILL. THE ALARM WAS NOTED AT THE FACILITY WHERE THE PT RESIDES FOR APPROXIMATELY 3 WEEKS, BUT NO ACTION WAS UNDERTAKEN. THE PT WAS ADMITTED TO THE HOSPITAL FOR EVALUATION OF POSSIBLE WITHDRAWAL SYMPTOMS. THE PT RETURNED TO THE FACILITY AND CONTINUED TO HAVE SYMPTOMS NOTED ABOVE. THE PT ALSO EXPERIENCED PERIODS OF HYPOTHERMIA, FELT TO BE SECONDARY TO SPINAL CORD INJURY. THE PUMP CONTENTS WERE NOT ASPIRATED PRIOR TO REFILL. THE PUMP WAS REFILLED; ONLY 35CCS WENT IN. A 50 MCG BOLUS WAS GIVEN AND THE PT WAS NOTED TO BLINK HIS EYES ON COMMAND. THE PT'S SYMPTOMS WERE "SUBSIDING" AND THE PT WAS TO BE MONITORED CLOSELY OVERNIGHT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| R