BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1890970 · Received October 29, 2010

    Report

    Report Number
    3007566237-2010-08648
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP SEEMED TO HAVE BEEN INFUSING MORE BACLOFEN (LIORESAL) THAN PROGRAMMED IN THE LAST MONTHS INSOFAR AS THE HEALTH CARE PROFESSIONAL (HCP) ALWAYS FOUND LESS DRUG THAN EXPECTED IN THE RESERVOIR. AT THE LAST REFILL 6 ML OF BACLOFEN WERE EXPECTED, BUT THE RESERVOIR WAS EMPTY. THE PUMP WAS FILLED WITH 10 ML OF "FISIOLOGICAL" SOLUTION AND ASPIRATED TO CHECK IF THE LAST REFILL WAS PERFORMED IN THE ISSUE AND NOT THE PUMP. THE ASPIRATED FLUID WAS EXACTLY 10 ML. CALCULATIONS SHOWED THAT THE PUMP DELIVERED 30% MORE THAN ESTIMATED BY THE NVISION. NO OVERDOSE SYMPTOMS WERE DETECTED OR REPORTED IN THE PT. THE PT ONLY REPORTED HYPERTONE WHEN THE MEDICATION RAN OUT. THE INFUSION PARAMETERS WERE BACLOFEN AT 2000 MCG/ML AT 400 MCG/DAY. THE HCP PLANNED TO "CHECK THE PUMP BEHAVIOR" BEFORE DECIDING WHETHER TO EXPLANT THE DEVICE. THE PUMP WAS SIX YEARS OLD. THE LOW BATTERY ALARM WAS CHECKED AND FOUND TO BE ENABLED AND NOT ACTIVATED. A FOLLOW-UP REPORT WILL BE SENT WHEN ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK MEDTRONIC NEUROMODULATION 8627 NA

    Patients

    Seq Age Sex Outcome Treatment
    1