BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3123910 · Received May 22, 2013

    Report

    Report Number
    3004209178-2013-08024
    Event Type
    Injury
    Date Received
    May 22, 2013
    Report Date
    April 30, 2013
    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
    AK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT# J11001R12, IMPLANTED: (B)(4) 2002, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    WAS LATER REPORTED THAT THE PATIENT FELT LIKE HE WAS NOT GETTING THERAPY. A CT SCAN WAS DONE AND DID NOT REVEAL ANYTHING. THE PUMP WAS INTERROGATED AND NO ALARMS WERE PRESENT. A CATHETER DYE STUDY WAS DONE. THE RADIOLOGIST WAS ABLE TO ASPIRATE SUCCESSFULLY. 5ML OF DYE WAS INJECTED BUT THE DYE COULD NOT BE SEEN ANYWHERE ON THE IMAGE. THE PATIENT THEN RETURNED TO THE CLINIC. THE PATIENT¿S HEALTHCARE PROVIDER (HCP) ALSO COULD NOT SEE ANY DYE ON THE IMAGE. A CATHETER REPLACEMENT WAS SCHEDULED FOR TWO WEEKS LATER. THE PUMP WAS ALSO TO BE REPLACED AS IT WAS CLOSE TO ITS ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS NOTED THAT THE VOLUMES HAD BEEN ¿OKAY¿ AT REFILLS. THREE HOURS AFTER THE DYE STUDY, THE PATIENT FELT LIGHTHEADED AND HIS LEGS FELT HEAVY. HOWEVER THE PATIENT WAS ABOUT TO GET ON A PLANE AND WAS TO RETURN TO THE CLINIC FOR A DECREASE FOLLOWING HIS FLIGHT. AFTER THE FLIGHT, THE PATIENT¿S LIGHTHEADEDNESS SUBSIDED BUT HIS LEGS WERE STILL HEAVY. THE PATIENT WAS TO HAVE HIS DOSE DECREASED ON THE DAY OF THE REPORT. THE CLINIC HAD BEEN INCREASING THE DOSE OVER THE PAST SIX WEEKS BECAUSE OF SOME RETURN OF SPASTICITY. THE TYPICAL DOSEFOR THE PATIENT HAD BEEN ABOUT 88MCG/DAY BUT HAD IT TURNED UP TO 100MCG/DAY. IT WAS NOTED THAT THE PATIENT WAS ¿HIGH FUNCTIONING¿ AND ¿VERY, VERY AWARE¿.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT CONTINUED TO HAVE CONCERNS ABOUT PUMP VIBRATION, HEARING ¿TONES¿ AND LACK OF THERAPEUTIC EFFECT. THE PATIENT DID NOT BELIEVE THAT IT WAS ¿MAKING IT INTO MY SPINAL CORD RIGHT NOW¿. THE PATIENT HAD AN APPOINTMENT WITH A NEUROSURGEON THE NEXT WEEK TO CHECK THE CATHETER. THE PUMP LOGS WERE CHECKED ON THE DAY OF THE REPORT AND NO PROBLEMS WITH THE PUMP WERE FOUND. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL 500MCG/ML. ON THE DAY OF THE REPORT, THE DOSE WAS INCREASED FROM 111.19MCG/DAY TO 112.28MCG/DAY.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PUMP WAS OBSTRUCTED, SO THE PATIENT WAS GOING TO NEED A NEW PUMP. IT WAS LATER REPORTED THAT A CATHETER BLOCKAGE OCCURRED.

    Description of Event or Problem · 1

    THE HCP REPORTED SINCE THE WINTER OF 2012 THE PATIENT FELT THE PUMP HAD BEEN ¿INADEQUATE¿. THE PATIENT REPORTED ¿FEELING LIKE THE PUMP WAS NOT WORKING RIGHT¿. THE PATIENT HAD A LEVEL OF DISCOMFORT/PAIN AND DEGREE OF SPASMS ALL THE TIME SINCE LAST WINTER WHEN THE PUMP DOSE WAS INCREASED. THE PATIENT¿S LEGS DO NOT "TURN TO JELLO" LIKE THEY USED TO. THE PATIENT ALSO BELIEVED HE HEARD A DOUBLE TONE BEEP FROM THE PUMP BUT AT A LOWER TONE THEN THE NORMAL PUMP ALARM WHICH OCCURRED. THIS OCCURRED SPORADICALLY AND HAD BEEN OCCURRING FOR APPROX. 2 MONTHS, SINCE (B)(6) 2013. FOLLOWING A REFILL IN (B)(6) 2012, DOSE INCREASES WERE DONE ON (B)(6) 2012 AND (B)(6) 2013 BUT IT DID NOT HAVE THE SAME POSITIVE EFFECT ON PATIENT AS BEFORE WHEN THEY WOULD INCREASE THE DOSE. THE PATIENT HAD ALSO NOTICED A VIBRATING SENSATION FROM THE PUMP WHICH OCCURRED SEVERAL TIMES IN AN HOUR AND ON MORE THAN ONE OCCASION WHICH BEGAN AROUND (B)(6) 2012. AT THE LAST REFILL, THE EXPECTED RESIDUAL VOLUME WAS 3.4 MLS AND ACTUAL RESIDUAL VOLUME WAS 2 TO 3 MLS. TROUBLESHOOTING OPTIONS WERE DISCUSSED WITH THE HCP. THE DEVICE WAS USED TO DELIVER LIORESAL. 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
    225853 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention