BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2834197 · Received November 15, 2012

    Report

    Report Number
    3007566237-2012-02728
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD INCREASING BACK PAIN AND WANTED TO HAVE BETTER PAIN CONTROL. AT THE REFILL, A 9% INCREASE IN INFUSION RATE WAS PROGRAMMED. THE PATIENT WAS PROGRAMMED TO HAVE 25 MG A DAY OF DILAUDID, BUT IN REALITY WAS ONLY RECEIVING 13 MG PER DAY OF DILAUDID DUE TO THE PROGRAMMING MISTAKE. THE PUMP WAS REPROGRAMMED WITH THE NEW MEDICATIONS, NEW VOLUME, AND A BRIDGE BOLUS. THE PATIENT SHOWED NO NEW NEUROLOGIC PROBLEMS AND WAS DISCHARGED IN GOOD CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED A BRIDGE BOLUS WAS INCORRECTLY PERFORMED. THE PUMP UPDATE WAS CANCELLED DUE TO THE VOLUME OF PUMP NOT BEING UPDATED. IT WAS REPORTED AFTER CORRECTING THE VOLUME THE PUMP WAS UPDATED WITH THE BRIDGE BOLUS NOW SHOWING "ONLY THE NEW CONCENTRATION." THE BRIDGE BOLUS THAT WAS IN PROGRESS WAS STOPPED AND UPDATED WITH A "MODIFIED" BRIDGE BOLUS. THE DRUG BEING USED IN THE PUMP WAS BUPIVACAINE AND DILAUDID (HYDROMORPHONE). ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1