BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3234133 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11979
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT COULD NOT USE THE "TYPICAL" FILL KIT FOR A REFILL AS THEIR PUMP WAS MOBILE. IT WASN'T ANCHORED LIKE A "NORMAL PUMP." THE PATIENT WAS SEEKING A PHYSICIAN THAT CAN FILL THE PUMP UNDER FLUOROSCOPY IN THEIR OFFICE. THE HOSPITAL HAD ISSUES WITH MEDICINE BEING BROUGHT IN FROM AN OUTSIDE SOURCE AS THEY CANNOT VERIFY THE DRUG. THE HOSPITAL DID NOT NORMALLY STOCK THE MEDICATION. THE HCP WAS BRINGING IN THE MEDICINE THAT HE HAD ORDERED AND IT WAS BEING SENT TO THE PHARMACY AND THE PHARMACY WAS SAYING THEY COULD NOT VERIFY WHAT MEDICATION IT WAS. THE PATIENT COULD NOT GO TO THE HOSPITAL FOR REFILLS DUE TO THIS. THE PATIENT'S MANAGING PHYSICIAN PLANNED TO REFILL THE PUMP ON (B)(6)2013. AFTER THAT THE PATIENT WOULD NEED A PHYSICIAN WHO HAS FLUOROSCOPY IN THEIR OFFICE. THE PATIENT WAS SEEKING A PHYSICIAN TO MANAGE HER CARE. THE PUMP WAS DELIVERING FENTANYL.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING THE DEVICE OR THERAPY BUT WAS WORKING WITH THE DOCTOR OR MANUFACTURER REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT DATE OF 2013 (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333764 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR