BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3230698 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-11877
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709 LOT# L74638, IMPLANTED: 2000 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S DEVICE WAS JUST ¿NOT COVERING THE PAIN AT ALL¿ AND HAD NOT BEEN HELPING FOR THE LAST TWO YEARS. IT WAS NOTED, IT HAD ¿GOTTEN WORSE¿ AS WELL. IT WAS STATED ¿SINCE I HAD A STROKE LAST YEAR IN MAY, THE PAIN LEVEL HAS JUST INCREASED AND INCREASED, WHERE I¿M HAVING TO TAKE PAIN MEDICATION ALONG WITH THE PUMP¿. THE THERAPY WAS NOT COVERING THE PATIENT¿S BACK OR LEGS BUT IT WAS THEN STATED ¿I GUESS IT IS COVERING IT TO THE POINT. I CAN¿T SAY IT¿S NOT. IT¿S COVERING SOME BUT IT GETS SO BAD I CRY AT NIGHT¿. SINCE THE PATIENT HAD THE STROKE, SHE COULD ¿REMEMBER HARDLY ANYTHING¿. THE PATIENT¿S HEALTH CARE PROVIDER (HCP) REPORTEDLY COULD NOT INCREASE THE MEDICATION ¿TOO MUCH¿ BECAUSE ¿IF THEY INCREASE IT LIKE THEY WANT TO I JUST GET LIKE I¿M OVERDOSED. I CAN¿T STAND UP. I CAN¿T DO ANYTHING. SO THEY HAVE TO DO IT VERY SLOWLY, WHEN THEY DO ANYTHING¿. IT WAS REPORTED THE PATIENT¿S NEUROLOGIST HAD STATED ¿MAYBE WE NEED TO CHANGE THE PUMP OUT, SINCE IT HASN¿T BEEN CHANGED SINCE 2007¿. IT WAS THEN NOTED THE ¿ONE OF THEM¿ WHEN REFERRING TO THE PATIENT¿S HCP ¿SAY IT¿S A POSSIBILITY THAT THE TUBING COULD HAVE SLIPPED¿ HOWEVER, THIS WAS NOT CONFIRMED AND NO FURTHER ACTIONS/TROUBLESHOOTING WERE REPORTED. THE PATIENT¿S MANAGING HEALTH CARE PROVIDER HAD ALSO DISCUSSED WITH THE PATIENT POSSIBLY INCREASING THE MEDICATIONS IN THE DEVICE. THE DEVICE SYSTEM CONTAINED DILAUDID AND CLONIDINE. 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
    328083 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Other