BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3971794 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13791
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 11, 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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8784, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER; PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY DID A DYE STUDY AS THEY SUSPECTED A CATHETER ISSUE BECAUSE THE THERAPY WAS NOT WORKING. THE DYE STUDY SHOWED NO ISSUES. IT WAS LATER REPORTED THAT THE PATIENT'S DOSE WAS UP TO 500 MCG/DAY BUT THE PATIENT FELT IT WAS NO LONGER WORKING AS SHE WAS STILL QUITE SPASTIC. THERE WAS NO DETERMINED CAUSE FOR THE LACK OF THERAPY, AND THE PUMP WAS NOTED TO BE FINE. THE EVENT WAS ATTRIBUTED TO THE PATIENT BEING RESISTANT TO BACLOFEN. A ROTOR AND DYE STUDY WERE DONE ON (B)(6) 2014. IT WAS NOTED THAT THEY HAD INCREASED THE PATIENT'S DOSAGE TO 600 MCG/DAY AND WOULD INCREASE IT AGAIN TOMORROW. THE PATIENT REPORTEDLY THOUGHT THE INCREASE TO 600 MCG/DAY MAY HAVE HELPED A LITTLE. THE HEALTHCARE PROFESSIONAL (HCP) REPORTEDLY TRIED BOTOX AND ALCOHOL INJECTIONS ALSO WITH LITTLE SUCCESS BUT PLAN TO TRY THE BOTOX AGAIN. THE PATIENT REPORTEDLY RECOVERED WITHOUT PERMANENT IMPAIRMENT, HOWEVER STILL HAD ONGOING SYMPTOMS. THE PATIENT'S PUMP WAS INFUSING LIORESAL. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446640 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR