BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5134468 · Received October 7, 2015

    Report

    Report Number
    3004209178-2015-20168
    Event Type
    Malfunction
    Date Received
    October 7, 2015
    Report Date
    September 16, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED BY THE COMPANY REPRESENTATIVE ON 2015-11-30, THAT THE INDICATION FOR USE WAS NEUROPATHIC PAIN IN THE BACK AND LEGS, AFTER A JOB INJURY WITH A FALL ON THE BACK. THE CAUSE OF THE EVENT WAS NOT KNOWN AND WAS IT FURTHER SPECIFIED THAT THE HEALTHCARE PROVIDER (HCP) HAS SWITCHED THE DRUG SOLUTION SEVERAL TIMES, BUT IT WAS STILL LIGHT YELLOW. THE ISSUE WAS REPORTEDLY RESOLVED BY THE HCP SWITCHING THE DRUG BEFORE THE ALARM DATE. REGARDING A POSSIBLE REVISION, THE HCP WAS TO DISCUSS THAT OPTION SOON, WITH THE COMPANY REPRESENTATIVE AND TECHNICAL SUPPORT. ADDITIONALLY, THE FOLLOWING DRUGS ARE INFUSED VIA SIMPLE CONTINUOUS MODE IN THE INTRATHECAL PUMP: BACLOFEN 400 MCG/ML WITH A DOSE OF 281.87 MCG/DAY; CLONIDINE 140 MCG/ML WITH A DOSE OF 98.65 MCG/DAY; AND MORPHINE 7500 MCG/ML WITH A DOSE OF 5281.1 MCG/DAY.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE IN (B)(6) REGARDING A PATIENT RECEIVING INTRATHECAL LIORESAL 0.4 MG/ML (DOSE UNKNOWN), CLONIDINE 0.14 MG/ML (DOSE UNKNOWN), AND MORPHINE 7.5 MG/ML (DOSE UNKNOWN) VIA AN IMPLANTED PUMP. THE LOT NUMBERS WERE UNOBTAINABLE. THE PUMP WAS IMPLANTED (B)(6) 2013. THE PATIENT'S MEDICAL HISTORY WAS UNKNOWN AT THIS TIME. ON APPROXIMATELY (B)(6) 2015, DURING A FOLLOW UP VISIT FOR A SCHEDULED REFILL THE PHYSICIAN NOTICED THAT THE REMAINING VOLUME IN THE PUMP WAS MAGNIFICENTLY HIGHER THAN EXPECTED AND EXTRACTING THE REMAINING DRUG IT SHOWED TO BE MIS-COLORED. THE DRUG WAS NOT CLEAR AS EXPECTED, BUT YELLOW. THE PATIENT'S EFFECT HAD DECLINED AND THE PAIN SYMPTOMS WERE WORSENING. TESTS FOR POSSIBLE INFECTION DID NOT SHOW ANY INDICATIONS. NO ACTIONS WERE TAKEN AND THE PUMP WAS STILL IN SERVICE. SURGICAL INTERVENTION DID NOT OCCUR AND WAS NOT PLANNED. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THIS REPORT AND THE PATIENT'S STATUS WAS "ALIVE- NO INJURY". ADDITIONAL INFORMATION HAS BEEN REQUESTED TO CLARIFY DOSING, INDICATION FOR USE, CAUSE OF THE EVENT, POSSIBLE TESTING RESULTS AND RESOLUTION, BUT THIS INFORMATION WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665021 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR