BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2974127 · Received February 22, 2013

    Report

    Report Number
    3004209178-2013-02982
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Report Date
    January 29, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A REFILL YESTERDAY AND THE HEALTH CARE PROVIDER (HCP) NOTICED A MOTOR STALL OCCURRED AND STOP PUMP PERIOD MAY EXCEED TUBE SET MESSAGES ON THE READOUT. IT WAS REPORTED THERE WAS NO VOLUME DISCREPANCY AT THE REFILL, THE HCP PULLED OUT 'ABOUT' 4.9 ML VERSUS 4 ML EXPECTED. THE HCP AND PATIENT DID NOT HEAR ANY ALARMS. IT WAS REPORTED THE PATIENT HAD HAD AT LEAST ONE MRI. IT WAS REPORTED THE PATIENT WAS CLINICALLY DOING WELL. IT WAS NOTED THE PUMP HAD BEEN IMPLANTED TO HELP WITH PHANTOM LIMB PAIN AND THE PATIENT HAD BEEN DEALING WITH BACK PAIN ISSUES FOR 'ABOUT TWO YEARS' BUT THERE WAS NO NOTABLE CHANGE IN THERAPY EFFECT. THE DEVICE SYSTEM WAS USED TO DELIVER BUPIVACAINE, COMPOUNDED BACLOFEN, AND MORPHINE. IT WAS LATER REPORTED THE PATIENT'S PUMP HAD NOT BEEN INTERROGATED FOLLOWING THE MRI. IT WAS REPORTED THE HCP NOTED A MOTOR RECOVERY OCCURRED YESTERDAY IN THE PUMP LOGS. 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
    78584 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1