BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3181447 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10676
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_PTM_PROG, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8711, LOT# N176161030, IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NOT BEEN GETTING ANY RELIEF WITH THE PUMP DESPITE DOSE INCREASES. IT WAS NOTED THAT THE PHYSICIAN WAS CAUTIOUS IN INCREASING IT, SO IT WAS NEVER INCREASED VERY MUCH. THE PHYSICIAN HAD SUGGESTED REPLACED THE PUMP BECAUSE OF THE LACK OF EFFECT. ON (B)(6), THE PATIENT FELL AND HURT HIS BACK. HE WAS BROUGHT TO THE HOSPITAL AND WAS LOADED UP ON PAIN MEDICATIONS. IT WAS FOUND THAT THE PATIENT HAD HERNIATED RUPTURED DISCS IN HIS BACK AND NECK. SURGERY WAS REQUIRED TO FUSE THE DISCS USING PINS AND SCREWS. AT THE TIME OF SURGERY, IT WAS DECIDED TO REPLACE THE PUMP AS WELL. AT THE TIME OF REPORT, THE PUMP CONTAINED MORPHINE, THOUGH IT WAS UNCLEAR IF THE MEDICATION HAD CHANGED SINCE THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283295 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention