BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2842050 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10633
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 24, 2012
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT PRESENTED WITH AN INFLAMMATORY MASS. THE PATIENT WAS SENT FOR AN MRI WHEN THE MASS WAS SUSPECTED. THE MAGNETIC RESONANCE IMAGING (MRI) WAS DONE WITH AND WITHOUT CONTRAST AND CONFIRMED A MASS AT THE CATHETER TIP BETWEEN T11 AND T12. THE DOSE WAS DECREASED SO THAT THE MASS COULD SHRINK. THE PATIENT IS DOING "AS WELL AS CAN BE EXPECTED" AND WILL CONTINUE TO EVALUATE OVER THE COMING WEEKS AS THEY DECREASE THE MEDICATION. WHEN THE INFLAMMATORY MASS IS DISSOLVED THEY WILL EXPLANT THE DEVICE AND GO BACK TO TAKING ORAL BACLOFEN. THE DRUG BEING USED IN THE PUMP WAS BACLOFEN AND HYDROMORPHONE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTHCARE PROFESSIONAL (HCP) DECREASED THE MEDICATION "VERY QUICKLY" AND TURNED THE PUMP OFF. IT WAS NOTED THAT THE HCP LEFT THE MEDICATION IN THE PUMP. IT WAS STATED THAT THE PUMP WAS STOPPED BECAUSE, IT "WAS NOT HELPING THE PATIENT." THE GRANULOMA WAS DISCOVERED 2 MONTHS AGO AND NO MEDICAL INTERVENTION HAD BEEN PLANNED OR PERFORMED. THE HCP PLANED ON USING THE PUMP IN THE FUTURE IF THE GRANULOMA DISSIPATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention