BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3803287 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08835
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    April 16, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PARTIAL EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE TO FOUR WEEKS PRIOR TO THE DATE OF THIS REPORT THE PATIENT FELL OUT OF A WHEELCHAIR AND SINCE THAT TIME WAS EXPERIENCING DIZZINESS, CONFUSION AND FEELING TIRED. AN X-RAY OF THE CATHETER WAS TAKEN, DATE UNKNOWN, AND IT WAS DISCOVERED THE CATHETER WAS FRACTURED. THE PATIENT HAS BEEN ON ORAL BACLOFEN. THE CATHETER WAS REVISED ON APRIL 16 AND THE SURGEON IMPLANTED A NEW 8780 ASCENDA CATHETER. THE PROXIMAL END OF THE OLD 8709 WAS EXPLANTED BUT THE INTRATHECAL END WAS LEFT IMPLANTED AS THIS WAS UNABLE TO BE REMOVED. THE PATIENT¿S DOSE WAS DECREASED AND THE PATIENT WAS TO STAY IN THE HOSPITAL OVERNIGHT. THIS DEVICE SYSTEM DELIVERED GABLOFEN. ADDITIONAL INFORMATION WAS REQUESTED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS FRACTURED AT THE DISTAL (SPINAL) SEGMENT UNDER THE ANCHOR. THE PATIENT¿S CONDITION TO DATE WAS NOT KNOWN BUT HE WAS KEPT OVERNIGHT TO MONITOR SYMPTOMS. THE CATHETER WAS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280502 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention