BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3240258 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12079
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 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 MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. PRODUCT ID: 8596, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. PRODUCT ID: 8575, LOT# J0333129R, IMPLANTED: (B)(6) 2004,EXPLANTED: (B)(6) 2007,PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PUMP REPLACEMENT PROCEDURE THE DAY PRIOR TO THE REPORT THE HEALTHCARE PROVIDER (HCP) NOTICED THAT THE PUMP SEGMENT OF THE CATHETER WAS DISCONNECTED FROM THE SPINAL SEGMENT OF THE CATHETER. THE SPINAL SEGMENT WAS FOUND TIED OFF; HOWEVER, THE HCP WAS UNSURE WHY IT HAD BEEN TIED OFF. A NEW PUMP WAS IMPLANTED AND A NEW PUMP SEGMENT CATHETER WAS ATTACHED TO THE EXISTING SPINAL SEGMENT. THE CALLER WAS TO PERFORM A CATHETER DYE STUDY TO CHECK THE PATENCY OF THE CATHETER. IF THE CATHETER WAS NOT PATENT, THE HCP WAS TO REPLACE THE CATHETER. THE DEVICE SYSTEM DELIVERED COMPOUNDED BACLOFEN. IT WAS LATER REPORTED THAT THE CALLER WAS UNSURE HOW MUCH MEDICATION THE PATIENT HAD BEEN RECEIVING OR IF HE WAS RECEIVING ANY MEDICATION AT ALL. IT WAS LATER REPORTED THAT THE PATIENT UNDERWENT AN INDIUM INJECTION AND TRACKING MEDICATION MOVEMENT VIA NUCLEAR MED SCANS. THE FIRST SCAN WAS PERFORMED ON (B)(6) 2013 AT WHICH TIME THE SCAN SHOWED NO MOVEMENT OF THE MEDICATION. ACCORDING TO CALCULATIONS MADE, IT WOULD TAKE 4.1-6.2 DAYS FOR INDIUM TO REACH THE END OF THE CATHETER ACCESS PORT (CAP). IT APPEARED THAT THE MEDICATION HAD NOT LEFT THE PUMP RESERVOIR. A SECOND SCAN WAS SCHEDULED FOR (B)(6) 2013. IT WAS NOTED THAT THE PATIENT¿S CONDITION WAS STABLE; HOWEVER, THE REPORTER WAS UNCERTAIN IF THE PATIENT WAS RECEIVING THERAPY AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339424 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR