BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3052026 · Received April 11, 2013

    Report

    Report Number
    3004209178-2013-05987
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 14, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING EFFECTIVE THERAPY AND HAS NOT HAD PAIN RELIEF, WHICH WAS NOTED TO HAVE STARTED APPROXIMATELY TWO WEEKS AGO. A DYE STUDY WAS GOING TO BE PERFORMED. THE PUMP SYSTEM WAS BEING USED TO DELIVER PRIALT. IT WAS ADDITIONALLY REPORTED THAT THE INTRATHECAL CATHETER HAD BEEN REMOVED FROM THE SPACE; THEREFORE, THE PHYSICIAN REVISED THE CATHETER AND ADDED A NEW SPINAL SEGMENT. THE PATIENT REMAINED ON THE SAME DOSE IF 1 MCG OF PRIALT/ DAY; CONCENTRATION UNKNOWN. IT WAS ADDITIONALLY REPORTED THAT THE EXPLANTED PORTION OF CATHETER WAS TAKEN BY THE HOSPITAL AND THE PATIENT WAS DOING WELL SINCE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154406 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention