BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2970362 · Received February 20, 2013

    Report

    Report Number
    3004209178-2013-02911
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    January 25, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8731SC LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE CATHETER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEY WERE TOLD THEIR PUMP NEEDED TO BE MOVED DOWN AND RE-SEWN IN PLACE BECAUSE, IT HAD FLIPPED SO MANY TIMES. THEY HAD TO FILL IT UNDER THE FLUOROSCOPE. THE PATIENT DID NOT GIVE AN EXACT DATE OF WHEN THIS HAPPENED. THE PATIENT STATED THAT WHEN THEY DID A DRUG TEST, SHE WAS TOLD THEY FOUND VALIUM IN HER SYSTEM AND THEN SHE WAS TOLD IT WAS MORPHINE SULFATE. THE PATIENT NOTED BEING TOLD THAT HER DOCTOR WILL NO LONGER TREAT HER AND THE PATIENT NEEDS A REFILL IN MARCH. THE PATIENT STATED SHE HAD PROOF OF WHAT WAS PUT INTO HER SYSTEM AND WANTED TO MEET WITH THE DOCTORS OFFICE AND THEY WILL NOT MEET. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. THE PUMP WAS DELIVERING DILAUDID AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74022 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1