BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 629255 · Received August 22, 2005

    Report

    Report Number
    2182207-2005-01310
    Event Type
    Injury
    Date Received
    August 22, 2005
    Report Date
    August 17, 2005
    Manufacturer
    MEDTRONIC, INC., NEUROLOGICAL DIVISION
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THE PATIENT PRESENTED TO THE CLINIC WITH RETURN OF SYMPTOMS INCLUDING INCREASED PAIN, HALLUCINATIONS, AND NAUSEA AND VOMITING. THE PUMP WAS INTERROGATED AND SHOWED "MOTOR STALL MESSAGE AND STOPPED PUMP MAY EXCEED TUBE SET." THE MOTOR STALL WAS DETERMINED TO HAVE OCCURRED ON 08/2005 AND CLEARED 08/2005. THE PATIENT WAS GIVEN A BOLUS THAT CLEARED THE MOTOR STALL. 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 MEDTRONIC, INC., NEUROLOGICAL DIVISION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention