BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1203510 · Received October 17, 2008

    Report

    Report Number
    2182207-2008-06665
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 18, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S ACTIVATED DOSE "CHANGED BY ITSELF DURING THE UPDATE". THE PHYSICIAN'S REFILL TRACKING LOG NOTED THAT THE PATIENT ACTIVATED (PA) DOSE PROGRAMMED IN 2008, WAS 1.997 MG/DOSE. THE PUMP WAS EXAMINED A WEEK LATER, AND IT WAS NOTED THAT THE LAST CHANGE OCCURRED ON ORIGINAL DATE, THE PA DOSE NOTED WAS 0.035 MG/DOSE. THE PUMP WAS REPROGRAMMED AND THE PA DOSE CHANGED TO 1.102 MG/DOSE, WHICH WAS VERIFIED ON THE PRINT AFTER THE PUMP UPDATE, AT 10:08AM A WEEK LATER. THE PUMP WAS NEXT EXAMINED SEVEN DAYS LATER AT 10:47 AM, AND TELEMETRY NOTED THE LAST CHANGE WAS A WEEK PRIOR AT 10:08 AM; THE PA DOSE WAS NOTED AS 0.025 MG/DOSE . THE PUMP WAS UPDATED AND THE PA DOSE WAS CHANGED TO 1.997 MG/DOSE AND WAS VERIFIED UPDATE. THE PUMP WAS INTERROGATED AGAIN 17 MINUTES LATER AND THE SETTINGS WERE THE SAME. THE PUMP WAS UPDATED WITH NO CHANGE TO THE PA DOSE, ONLY AN INCREASE IN THE SIMPLE CONTINUOUS DOSE. THE PUMP WAS INTERROGATED AGAIN 8 MINUTES LATER AT 11:15. TELEMETRY NOTED THE LAST CHANGE WAS MADE AT 11:15 AM (NO TELEMETRY STRIPS WERE NOTED DURING THIS TIMEFRAME). THE PA DOSE WAS NOTED TO BE 0.025 MG/DOSE. NO FURTHER CHANGES WERE MADE TO THE PUMP DOSING AND THE MANUFACTURER'S REPRESENTATIVE WAS NOTIFIED FOR CONSULTATION. ADDITIONAL INFORMATION RECEIVED, REPORTED THAT REVIEW OF THE PATIENT THERAPY MANAGER (PTM) NOTED THE "RX" ICON WAS NOT SHOWING ON THE DISPLAY, AND AN EXTRA ICON WAS SHOWING ON THE START UP SCREEN (NO DESCRIPTION OF THE ICON WAS PROVIDED). IT WAS NOTED THAT THE ISSUES WITH THE CHANGING PATIENT ACTIVATED DOSE BEGAN AFTER THE PATIENT GOT A NEW PTM. ISSUES WITH LOCKOUT AT NON-LOCKOUT TIMES WERE ALSO REPORTED. NO PATIENT SYMPTOMS OR OUTCOME WAS REPORTED. THE PATIENT'S PUMP CONTAINED MORPHINE, BUPIVACAINE, AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR EXPLANTED:| PROGRAMMER: MODEL 8832| PROGRAMMER: MODEL 8840| CATHETER: MODEL 8709SC| IMPLANTED: