BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3123992 · Received May 22, 2013

    Report

    Report Number
    3007566237-2013-01703
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Report Date
    April 25, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8596, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER; PRODUCT ID 8598, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER; PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REFILL, BOTH THE EMPTY RESERVOIR ALARM AND LOW RESERVOIR ALARM OCCURRED SIMULTANEOUSLY. THE HEALTHCARE PROFESSIONAL (HCP) HAD INITIALLY INTERROGATED THE PUMP AND FOUND THAT THE RESERVOIR VOLUME WAS AT 4ML, BUT THE PUMP ACTUALLY HAD CONTAINED 2.8ML OF DRUG. THE PROGRAMMER SHE WAS USING HAD SOME ¿BATTERY STUFF¿ AND WAS REPORTEDLY GOING ¿SUPER SLOW¿, SO THE HCP STOPPED UPDATING AND CHANGED TO A NEW PROGRAMMER. AT THAT POINT THE TWO ALARMS TRIGGERED, THOUGH THE RESERVOIR VOLUME STILL SHOWED 4ML. THE HCP UPDATED THE VOLUME TO 20ML WITH THE FIRST PROGRAMMER, BUT HAD TO REDO THE UPDATE WITH THE SECOND PROGRAMMER. THE UPDATE WAS SUCCESSFULLY COMPLETED USING THE SECOND PROGRAMMER AS IT SHOWED THE RESERVOIR VOLUME AND REFILL DATE TO BE CORRECT. IT WAS STATED THAT THE PUMP CONTAINED BACLOFEN. ONE WEEK LATER, IT WAS REPORTED THAT THE PRINTOUT DURING THE FIRST UPDATE SHOWED THE RESERVOIR VOLUME WAS AT 4.0ML AND THE LOW RESERVOIR ALARM WOULD OCCUR AT 2.0ML. THE EMPTY AND LOW RESERVOIR ALARMS BOTH OCCURRED AT 3:49PM, ONE MINUTE AFTER THE REFILL OCCURRED. AFTER THE FIRST UPDATE, THE LOW RESERVOIR ALARM DATE HAD CHANGED FROM (B)(6) WHICH WAS THE DATE OF THE REFILL AND BOTH OF THE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225888 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1