BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1062909 · Received June 19, 2008

    Report

    Report Number
    3004209178-2008-03362
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    April 10, 2008
    Report Date
    May 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY DEVICE ANALYSIS WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS EXPERIENCING MINIMAL PAIN RELIEF SINCE IMPLANT OF THE PUMP IN LATE 2007. THE DRUG USED IN THE PUMP IS MORPHINE 10 MG/ML. THE DOSE HAD BEEN INCREASED FROM 1 MG/DAY TO 6 MG/DAY. WHEN THE DEVICE WAS DUE FOR REFILL, 40 MLS OF DRUG WERE ASPIRATED. THE PUMP HAD NOT DELIVERED ANY MEDICATION. NO ALARMS WERE NOTED TO HAVE OCCURRED. NO MOTOR STALL OR STOPPED PUMP ALARMS WERE NOTED. A CATHETER ACCESS PORT PROCEDURE REVEALED AN INABILITY TO ASPIRATE CSF OR INJECT CONTRAST. CATHETER REVISION SURGERY WAS PERFORMED, BUT UPON DISCONNECTING THE PUMP, CSF BACKFLOW WAS NOTED INDICATING A PATENT CATHETER. THE DECISION WAS MADE TO REPLACE THE PUMP. THE DOSE OF MORPHINE WAS REDUCED TO 1 MG/ML. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 NA

    Patients

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