BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5185460 · Received October 28, 2015

    Report

    Report Number
    3004209178-2015-21722
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Report Date
    October 8, 2015
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8578, LOT # 0207291230, PRODUCT TYPE ACCESSORY; PRODUCT ID 870953, SERIAL # (B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A COMPANY REPRESENTATIVE IN REGARDS TO A PATIENT WHO RESIDED IN CANADA AND HAD AN INTRATHECAL BACLOFEN PUMP IMPLANTED. IT WAS NOT REPORTED WHAT TYPE OF BACLOFEN, THE MANUFACTURER, DOSE, CONCENTRATION, OR LOT #. THE PATIENT¿S MEDICAL HISTORY WAS UNABLE TO BE OBTAINED. THE PATIENT¿S MOTHER INQUIRED ABOUT INFORMATION REGARDING DOCTORS WHO LOOK AFTER INTRATHECAL BACLOFEN PUMP LOCATED WITHIN THE PATIENT¿S AREA. THE PATIENT¿S MOTHER WAS TRYING TO FIND OUT IF THERE WAS AN ISSUE WITH THE PATIENT¿S CATHETER, AS THE PATIENT EXPERIENCED MORE PAIN AND MORE SPASTICITY. IT WAS BELIEVED BY THE CONSUMER THAT THE ¿CATHETERS WERE NOT WORKING ON THE PUMP.¿ THE DATE OF THE EVENT WAS REPORTED TO HAVE BEEN ON APPROXIMATELY (B)(6) 2015. THE CONSUMER WAS ADVISED TO CONTACT THE REHAB CLINIC AND TO GET A REFERRAL TO GET INTO ANOTHER CENTER. ADDITIONALLY, THE CONSUMER WAS ADVISED TO WORK WITH DOCTORS TO DETERMINE IF THERE WERE ANY ISSUES. AS OF THE DATE OF THIS REPORT, THE ISSUE HAD NOT BEEN RESOLVED AND THE PATIENT WAS ALIVE WITHOUT INJURY. NO SURGICAL INTERVENTION HAD OCCURRED OR WAS PLANNED. THE CONSUMER PLANNED TO REACH OUT TO A DOCTOR TO DISCUSS THE ISSUE FURTHER. ANY ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714067 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1