BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202638 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-01485
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    May 7, 2012
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR THE LAST TWO OR THREE MONTHS THE TOP OF THE PATIENT¿S LEGS GOT REALLY COLD AND STAYED COLD WHENEVER THE PATIENT GAVE HERSELF A BOLUS OF MEDICATION. THE COLD FEELING STARTED AT THE PUMP AND THEN TRAVELED SLOWLY ALONG THE CATHETER PATH TO THE PATIENT¿S BACK. IT WAS NOTED THAT OVER THE LAST SIX WEEKS THE PATIENT¿S DOSE WAS INCREASED 27 PERCENT. THE PATIENT¿S PUMP WAS REPROGRAMMED TWO WEEKS PRIOR TO THE DATE OF THIS REPORT. THE PATIENT WAS STILL EXPERIENCING PAIN AND WAS NOT GETTING ANY PAIN RELIEF AT ALL. THE THOUGHT WAS THAT THE CATHETER WAS LEAKING. THE PATIENT HAD DILAUDID IN HER PUMP AND IN (B)(6) 2012 FENTANYL WAS PUT IN. THE FENTANYL IN THE PUMP WORKED WELL UNTIL ABOUT 6 WEEKS AGO. NO TRAUMA OR FALL WAS NOTED AT THAT TIMEFRAME. THE PHYSICIAN SUSPECTED THAT THE PATIENT JUST NEEDED A HIGHER DOSE. A PUMP ROLLER STUDY WAS PERFORMED, BUT THE RESULTS OF THE STUDY WERE NOT KNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT AS OF THE DATE OF THIS REPORT, THE PATIENT STILL HAD A COLD SENSATION THAT RADIATED DOWN HER LEG WHEN SHE GAVE HERSELF A BOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301313 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR