BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2844030 · Received November 24, 2012

    Report

    Report Number
    3004209178-2012-10720
    Event Type
    Malfunction
    Date Received
    November 24, 2012
    Report Date
    October 26, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING PAIN RELIEF. THE PATIENT JUST RECENTLY HAD THE PUMP IMPLANTED. THE PATIENT HAD BEEN WAKING UP IN PAIN, WHICH IS RELIEVED WHEN STIMULATOR TURNED BACK ON. THE PATIENT NOTED THAT THEY ALSO HAVE A STIMULATOR ON THE OPPOSITE SIDE OF THE PUMP AND THEY TURN THE STIMULATOR ON AND OFF USING A MAGNET. PATIENT STATED HE HASN'T PLACED OVER PUMP, BUT WAS WONDERING IF PUMP WAS WORKING AS PAIN RETURNS IN THE MORNING. THE PATIENT DENIED HEARING ANY ALARMS AND JUST HAD PUMP REFILL THE DAY PRIOR TO THE REPORT DATE. THE PATIENT NOTED THAT THE HEALTHCARE PROVIDER (HCP) WAS INCREASING DOSAGE AS THE PATIENT HAD SEVERAL UPCOMING APPOINTMENTS, FOR THE PUMP. IT WAS CONTEMPLATED THAT SINCE THE HCP WAS SLOWLY TITRATING THE PUMP DOSAGE, THE PATIENT MAY NOT BE RECEIVING AN OPTIMAL LEVEL OF PAIN RELIEF FROM THE PUMP AND THE PATIENT WOULD HOPEFULLY NOTICE IMPROVEMENT AS THE HCP ADJUSTED THE DOSAGE. THE PATIENT NOTED SINCE RECEIVING PUMP THERE HAD BEEN A DECREASE OF ORAL MEDICATION, SELF-ESTEEM HAD INCREASED AND THE PATIENT WAS STARTING TO WALK. THE MEDICATION IN THE PUMP WAS MORPHINE. 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
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1