BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4140715 · Received October 3, 2014

    Report

    Report Number
    3004209178-2014-18291
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    July 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PHYSICIAN PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A MOTOR STALL. WHILE THE PATIENT WAS AT A REFILL ON THE DATE OF THE REPORT, IT WAS DISCOVERED THE PATIENT HAD AN MRI ON (B)(6). THE PUMP WAS READ AFTER THE MRI, BUT THE PUMP TOOK 3 HOURS TO SHOW MOTOR RECOVERY. WHEN THE PUMP REPORT WAS PRINTED AT THE REFILL, IT WAS NOTED THE PUMP WAS PROGRAMMED TO STOP PUMP MODE AND FLEX MODE WAS REPROGRAMMED. IT WAS NOT KNOWN IF THE CLINIC HAD TELEMETRY INTERFERENCE OR TROUBLE UPDATING THE PUMP. THERE WERE NO CLINICAL SYMPTOMS. IT WAS LATER REPORTED THERE WAS A LACK OF APPEARANCE OF A MOTOR STALL AFTER AN MRI. NO PUMP MOTOR STALL OR MOTOR STALL RECOVERY WAS SEEN. IT WAS REPORTED THE PUMP WAS NOT PROGRAMMED TO STOP PUMP MODE. THE NURSE UPDATED THE PUMP TO GET THE LOGS AND THEN WENT BACK TO INTERROGATE THE PUMP AND IT WAS IN STOPPED PUMP MODE. THE PUMP HAD TO BE REPROGRAMMED BACK TO FLEX DOSING MODE AND UPDATED. NO OTHER TROUBLESHOOTING OR ACTIONS WERE TAKEN TO RESOLVE THE EVENT. THE PATIENT WAS DOING WELL. THE SYSTEM WAS BEING USED TO DELIVER LIORESAL BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620877 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00009 YR