BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3884911 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-11835
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NORMAL PUMP REPLACEMENT CONFIRMED TO BE DUE TO A PUMP NEARING ERI (ELECTIVE REPLACEMENT INDICATOR)/EOS (END OF SERVICE) THE SURGEON ONLY GOT BUBBLES BACK WHEN ASPIRING THE CATHETER. THE REPORTER WASN¿T CERTAIN IF ALL DRUG WAS REMOVED FROM THE CATHETER SO THEY DECIDED TO DO A BACK TABLE PRIME AND BRIDGE THE CATHETER VOLUME ONLY. IT WAS NOTED 1000 MCG/ML WAS IN THE CATHETER AND 2,000 MCG/ML WAS IN THE PUMP TUBING AND PUMP RESERVOIR. BRIDGE BOLUS INFORMATION WAS REVIEWED AND THE CATHETER VOLUME WAS BRIDGED. THE PATIENT HAD BEEN DOING WELL WITH THERAPY, GOOD SPASTICITY CONTROL PER THE REPORTER. THEY DID NOT SUSPECT A CATHETER ISSUE. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN AT DOSE OF 147 MCG/DAY WITH THE CURRENT CONCENTRATION BEING 1 ,000 MCG/ML AND THE NEW CONCENTRATION BEING 2,000 MCG/ML. IT WAS FURTHER REPORTED THE DEVICE MANUFACTURER REPRESENTATIVE DIDN¿T KNOW THE CAUSE OF THE DIFFICULTY WITH ASPIRATION. THE SURGERY WAS ON THE DATE OF THIS REPORT AND THE REPRESENTATIVE DIDN¿T KNOW ABOUT THE PATIENT¿S STATUS. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359903 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR