BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3973162 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13813
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 3, 2014
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. PRODUCT ID: 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014 INFORMATION WAS RECEIVED FROM A REPRESENTATIVE INDICATING THE PATIENT HAD BEEN RECEIVING LIORESAL 2000 MCG/ML AT 208 MCG/DAY. THEY WERE ALSO TAKING ORAL BACLOFEN AS NEEDED. THE PATIENT EXPERIENCED A URINARY TRACT INFECTION (UTI) WITH AN INCREASE IN TONE. THEIR DOSE WAS INCREASED. THEY WERE SENT TO THE SURGEON FOR A DYE STUDY WHICH REVEALED THE CATHETER WAS PROPERLY LOCATED, THOUGH THERE WAS A POOR DISTRIBUTION OF FLOW. AN MRI WAS ORDERED AND SHOWED A POSSIBLE SYRINX. X-RAY RESULTS WERE WITHIN NORMAL LIMITS AND SHOWED THE CATHETER WAS INTACT AND CONNECTED TO THE PUMP. THE CATHETER TIP WAS LOCATED AT T7. THE PATIENT¿S DOSE WAS TITRATED UP WITH GOOD RESPONSE. THEY WERE SEEN ON (B)(6) 2014 AND THEIR DOSE WAS TITRATED UP TO 598 MCG/DAY. THE PATIENT¿S SPASMS WERE RESOLVING. THEY WERE THEN SEEN ON (B)(6) 2014 FOR A REFILL AND THE DOSE WAS INCREASED BY 10% TO 653 MCG/DAY. THEIR PHYSICIAN NOTED MILD SPAMS WITH MOBILITY.

    Description of Event or Problem · 1

    THE PATIENT HAD A PUMP REPLACEMENT IN (B)(6) AND BEGAN HAVING DIFFICULTY MAINTAINING SPASM CONTROL. A DYE STUDY WAS PERFORMED, AND THE PATIENT HAD A SPINAL CATHETER REPLACEMENT IN (B)(6). THEY CONTINUED TO REPORT INTERMITTENT SPASTICITY ISSUES. AN MRI WAS COMPLETED AND SHOWED A STABLE SYRINX AT THE T3-T4 LEVEL. THEY WERE UNABLE TO DETERMINE THE CAUSE OF THE INCREASED TONE, AND THEY WERE STILL IN THE DIAGNOSTIC PHASE. A ROLLER STUDY AND X-RAY WERE ALSO REPORTEDLY PERFORMED, THOUGH THE RESULTS WERE NOT PROVIDED. INCREASED SPASTICITY OF THE RIGHT LEG WAS ALSO REPORTED. THE PATIENT¿S STATUS AT THE TIME OF THE REPORT WAS ALIVE WITH NO INJURY. THE MEDICATION INFUSED WAS BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450206 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention