BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3951008 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13375
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    July 1, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER; PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A POSSIBLE DECREASE IN THERAPY EFFECT. THE EVENT REQUIRED NO ACTION. A DYE STUDY WAS COMPLETED WITH NORMAL ASPIRATION AND THE DYE WAS VISUALIZED IN THE INTRATHECAL SPACE. THE FULL LENGTH OF THE CATHETER WAS EXAMINED UNDER X-RAY AND NO OBVIOUS ISSUES WERE FOUND. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ¿ALIVE- NO INJURY.¿ THE SYSTEM WAS BEING USED TO DELIVER LIORESAL. IT WAS LATER REPORTED THE PUMP AND CATHETER APPEARED TO BE WORKING AS EXPECTED. IT WAS LATER REPORTED THE PUMP WAS BEING USED TO DELIVER GABLOFEN. THE PATIENT WAS EXPERIENCING BREAKTHROUGH MULTIPLE SCLEROSIS SPASMS. THE CAUSE OF THE EVENT WAS NOT KNOWN BUT ATTRIBUTED TO THE CATHETER. THE EVENT WAS NOT DUE TO DRUG EFFECTS OR PROGRAMMING. THE DOSE WAS ADJUSTED TO NO EFFECT. A DYE STUDY WAS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427873 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR