BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC SYNCHROMED II PROGRAMMABLE PUMP

    MDR report key: 1033397 · Received April 23, 2008

    Report

    Report Number
    MW5006374
    Event Type
    Death
    Date Received
    April 23, 2008
    Date of Event
    February 20, 2008
    Report Date
    April 23, 2008
    Manufacturer
    MEDTRONIC
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A BACLOFEN INFUSION PUMP WAS IMPLANTED FOR TREATMENT OF LOWER EXTREMITY SPASTICITY DUE TO MULTIPLE SCLEROSIS. PUMP WAS PLACED IN LATE 2007. IN EARLY 2008, THE PT HAD ALTERED MENTAL STATUS AND WAS BROUGHT TO THE HOSP WHERE A HEAD CT SHOWED "CHRONIC BILATERAL SUBDURAL HEMATOMAS WITH SUPERIMPOSED ACUTE HEMORRHAGE." SURGICAL INTERVENTION WAS NOT INDICATED, AND HIS CONDITION DETERIORATED UNTIL HIS DEATH ON THE FOLLOWING MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SYNCHROMED II PROGRAMMABLE PUMP BACLOFEN INFUSION PUMP LKK MEDTRONIC 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Death