BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3203508 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-02547
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 16, 2012
    Report Date
    July 25, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PAIN RELIEF FOR THE PATIENT ¿IS NOT AS GREAT AS HE WOULD HOPE¿. IT WAS REPORTED THAT THE PATIENT CAME IN LATE FOR A DRUG RESERVOIR REFILL AND HAD ¿MULTIPLE AREAS OF PAIN¿. THE PATIENT STATED THEY WOULD LIKE FOR THE PUMP TO BE ABLE TO RUN IN FLEX DOSING MODE AND ALSO HAVE THE PTM. PATIENT WILL BE DISCUSSING OPTIONS WITH HIS HCP. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN, BUPIVACAINE, AND METHADONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301454 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR