BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5058113 · Received September 4, 2015

    Report

    Report Number
    3004209178-2015-17384
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    April 28, 2015
    Report Date
    August 12, 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-1, LOT# N232986, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL (HCP) REPORTED A PATIENT RECEIVING INTRATHECAL GABALON (LOT # UNKNOWN, CONCENTRATION 500 MCG/ML, DOSE 69.27 MCG/DAY) FOR INTRACTABLE SPASTICITY, MULTIPLE SCLEROSIS AND CLARITHROMYCIN HAD AN MAGNETIC RESONANCE IMAGING (MRI) PERFORMED AND A MOTOR STALL WAS NOTED UPON INITIAL INTERROGATION. THE MOTOR STALL OCCURRED ON (B)(6) 2015. THE MRI WAS NOT RELATED TO THE DEVICE OR THERAPY. THE INITIAL REPORT INDICATED THE MOTOR STALL HAD NOT RECOVERED AND WAS INTERROGATED MORE THAN 2 HOURS AFTER THE PATIENT EXITED THE MRI FIELD. ADDITIONAL INFORMATION RECEIVED FROM THE SAME HCP REPORTED THE PUMP WAS INTERROGATED AGAIN AND A MOTOR STALL RECOVERY WAS RECORDED IN THE LOGS. THE MOTOR STALL RESOLVED. THE PATIENT HAD SYMPTOMS OF INCREASED SPASMS IN THE SIDE/FLANK THAT OCCURRED GRADUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589862 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR