BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3200050 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-11132
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 7, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8575, LOT# N123021, IMPLANTED: (B)(6) 2007, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP ¿SHUT DOWN¿ AND WAS NOT DELIVERING MEDICATION. THE PATIENT STATED THAT ABOUT 1 MONTH AGO 6 CC'S SHOULD HAVE BEEN DELIVERED BUT IT WAS NOT DELIVERED BY HER PUMP. THE HCP AT THAT TIME CHECKED WITH HIS ¿COMPUTER¿ AND IT SHOWED THE PUMP WAS ¿WORKING FINE¿. THE HCP HAD THE PATIENT COME BACK 30 DAYS LATER AND WHEN THE HCP CHECKED HER PUMP WITH HIS ¿COMPUTER¿ AND STATED AGAIN HER PUMP WAS WORKING FINE. THE PATIENT HAD A REFILL THE DAY BEFORE THE REPORT AND PER THE PATIENT THE HCP PUT IN 40ML THE LAST TIME HE REFILLED. THE HCP PULLED OUT 40ML AT THE REFILL SO IT DIDN'T DELIVER ANYTHING; NO MEDICATION WAS DELIVERED FOR THE ENTIRE PAST MONTH. PER THE PATIENT STATES THE HCP "FREAKED OUT" WHEN THE HCP SAW NO MEDICATION WAS DELIVERED. THE PATIENT INDICATED THAT THEY WOULD BE OUT OF STATE (B)(6) FOR 2 MONTHS AND THE HCP GAVE THE PATIENT AN ORAL PAIN PRESCRIPTION FOR THE TIME SHE WOULD BE GONE OF 60 MG FAST RELIEF MORPHINE 3 TIMES A DAY SINCE PUMP WAS NOT WORKING AT ALL. THE PATIENT WOULD NOT BE AVAILABLE TO HAVE PUMP CHECKED UNTIL SHE COMES BACK AND PLANNED TO CONTACT THE HCPS OFFICE WHEN SHE CAME BACK. PER THE PATIENT THE ¿PUMP BATTERY¿ WAS CHECKED AT THE LAST MONTHS REFILL AND WAS ¿GOOD FOR ANOTHER 15 MONTHS¿. THE PATIENT ALSO STATED ¿THEIR BLOOD PRESSURE GOES UP¿ WHEN ¿THEIR PAIN LEVEL GOES UP¿ AND THEIR BLOOD PRESSURE WAS ¿QUITE HIGH¿ AT THE REFILL. THE HCP FILLED THE PUMP WITH SALINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297481 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR