BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 858717 · Received May 31, 2007

    Report

    Report Number
    2182207-2007-01883
    Event Type
    Malfunction
    Date Received
    May 31, 2007
    Date of Event
    February 12, 2007
    Report Date
    May 3, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE REPORTED, THE PATIENT'S PUMP BEGAN ALARMING IN 2007. THE PATIENT WAS EXPERIENCING A RETURN OF SYMPTOMS. THE DRUG USED IN THE PUMP IS BACLOFEN 250 MCG/ML AT 55 MCG/DAY. THE PUMP WAS INTERROGATED AND A MOTOR STALL MESSAGE APPEARED. THE LOGS SHOW "STOPPED PUMP" MESSAGE FOR 2/13/2007. A STUDY WAS PERFORMED WHICH SHOWED THE ROTOR APPEARED TO MOVE ON X-RAY OVER TWO BOLUSES. A MOTOR STALL RECOVERY MESSAGE APPEARED ON THE LOGS FOR 2/19/2007. THE ALARM CONTINUED AND ACTUAL RESERVOIR VOLUMES WERE LARGER THAN EXPECTED. A CATHETER DYE STUDY WAS DONE AND THE CATHETER WAS PATENT. SINCE THE RESERVOIR VOLUMES CONTINUED TO VARY, THE ALARM WAS SILENCED ON 3/19/2007. AND THE PUMP WAS REPLACED ON 5/3/2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| CATHETER MODEL CATHETER LOT# UNKNOWN