BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1180193 · Received September 29, 2008

    Report

    Report Number
    2182207-2008-06183
    Event Type
    Injury
    Date Received
    September 29, 2008
    Report Date
    August 28, 2008
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED SYMPTOMS OF AN INCREASE IN PAIN. TELEMETRY LOGS INDICATED A MOTOR STALL OCCURRED WITH NO RECOVERY AND A "STOPPED PUMP PERIOD MAY EXCEED TUBE SET" ERROR MESSAGE. NO VOLUME DISCREPANCIES WERE NOTED UNTIL THE MOTOR STALL OCCURRED. THE CRITICAL MOTOR STALL ALARM WAS ACTIVE. THE DEVICE WAS REPLACED. THE DRUG IN THE PUMP WAS MORPHINE TARTRATE AT A CONCENTRATION OF 40 MG/MLS AND A DOSE OF 5 MG/DAY. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| IMPLANTED| PROGRAMMER MODEL 8840 LOT# UNK| CATHETER MODEL CATHETER LOT# UNK