BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3884329 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-11818
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    May 28, 2014
    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
    NV, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS TO HAVE A MAGNETIC RESONANCE IMAGING (MRI) AND IT WAS UNKNOWN IF THE MRI WAS RELATED TO THE DEVICE OR THERAPY. IT WAS NOTED THE PATIENT WAS HAVING A LOT OF PAIN IN HIS MIDDLE BACK. IT WAS ALSO REPORTED, ¿DON¿T KNOW IF THE MACHINE WAS DOING ITS JOB HE WOULD NOT BE IN PAIN OR IF AS HIGH AS THE CATHETERS ARE ALLOWED TO GO THEY DON¿T REACH WHERE HE WAS FEELING PAIN.¿ IT WAS ALSO REPORTED THEY WERE AFRAID OF THE PATIENT¿S LUNGS BEING AFFECTED BY THE MEDICATION ¿SO THEY CAN ONLY GO SO HIGH UP.¿ IT WAS NOTED THE PATIENT HAD DIFFERENT KINDS OF PAIN AND HE WAS A QUADRIPLEGIC SO HE WAS PARALYZED FROM THE NIPPLE/ELBOW LINE DOWN. IT WAS ALSO REPORTED THE PATIENT COULD FEEL ABOVE THE NIPPLE LINE FROM HIS BACK AND ALSO HE HAD SWELLING. THE PATIENT HAD A LOT OF NERVE PAIN AND WAS ALSO A DIABETIC AND ¿HE¿S ALWAYS HAD THIS KIND OF PAIN.¿ THE PATIENT HAD SWELLING ¿IN THE LEFT SIDE SCAPULA ALL THE WAY FROM THE TOP OF HIS SHOULDER ALL THE WAY DOWN TO THE MIDDLE OF HIS BACK AND AROUND TO THE OTHER SIDE, BUT THE SWELLING WAS MOSTLY FROM THE MIDDLE LEFT TO THE LEFT AND SOME ON TOP OF THE RIGHT SHOULDER.¿ IT WAS ALSO REPORTED THE HEALTHCARE PROVIDER INDICATED THE PATIENT COULD NOT GO ANY HIGHER WITH THE MEDICATION IN THE PUMP. IT WAS UNKNOWN WHAT SPECIFIC DRUGS THE PUMP WAS BEING USED TO DELIVER, BUT THE PATIENT WAS RECEIVING INTRATHECAL BACLOFEN THERAPY. IT WAS REPORTED, ¿THEY ARE ALWAYS TRYING DIFFERENT THINGS ON HIM.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359918 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1