BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2882240 · Received December 20, 2012

    Report

    Report Number
    3004209178-2012-12102
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    FOR APPROXIMATELY 10 DAYS, THE PATIENT HAD HAD EXTREMELY HIGH TONE, LIKE "WITHDRAW TONE". THERE WERE NO KNOWN ISSUES, SUCH AS AN ACCIDENT OR TRAUMA THAT MIGHT HAVE CAUSED IT. THE PATIENT WAS ADMITTED TO THE HOSPITAL TO "CHECK HER OUT". ON (B)(6) 2012, THEY GAVE HER A "BUNCH OF BACLOFEN" AND THEN WANTED TO SEE HOW SHE DID. THE NEXT DAY, SHE WAS REPORTED TO BE "FINE". ON (B)(6) 2012, IT WAS REPORTED THAT THE PATIENT CONTINUED TO HAVE INTERMITTENT LOSS OF TONE. THE WEEK PRIOR IN THE ER THEY HAD GIVEN HER A 50 MCG THOUGH HER PUMP; IT DID NOTHING FOR HER. THEN WHEN THEY DID THE ROLLER STUDY AND THE DYE STUDY ABOUT 3 HOURS LATER, THEY GAVE HER 20 MCG FOR THE ROLLER STUDY AND 20 MCG FOR THE DYE STUDY AND THEN INCREASED THE PUMP DOSE BY 50 MCG/DAY. BY 9:00 PM THAT NIGHT, SHE WAS "KNOCKED OUT", SO THEY FIGURED THAT THE PUMP WAS WORKING; THAT THE PATIENT WAS GETTING DRUG. THE DEVICE SYSTEM WAS DELIVERING LIORESAL.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT HAD BEEN IN THE HOSPITAL "A FEW TIMES" IN (B)(6) 2012. THE REPORTER WAS UNABLE TO COMMUNICATE WITH THE PATIENT'S IMPLANTING AND MANAGING PHYSICIAN AND FELT UNEASY WITH A DIFFERENT DOCTOR TAKING OVER AND WANTING TO DO SURGERY. THE REPORTER AND PATIENT RECEIVED ASSISTANCE FROM A MANUFACTURER REPRESENTATIVE WHO WAS ABLE TO SPEAK TO THE DOCTORS AND EASE THE REPORTER'S CONCERNS AND FEARS. THE REPORTER STATED "HE MADE ME FEEL SO MUCH BETTER ABOUT THE WHOLE SITUATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR Hospitalization