BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3222259 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11641
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 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
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8596, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4). FINAL DEVICE ANALYSIS OF THE CATHETER 8596 REVEALED THE FOLLOWING: THERE WERE NO SIGNIFICANT ANOMALIES FOUND. THE CATHETER WAS NOT RETURNED WHOLE. IT WAS MISSING THE PROXIMAL STRAIN RELIEF SLEEVE. THERE WAS FOREIGN MATERIAL DEPOSITED ON THE DISTAL END. FINAL DEVICE ANALYSIS OF THE CATHETER 8709 REVEALED THE FOLLOWING: THERE WERE NO SIGNIFICANT ANOMALIES FOUND. THE CATHETER WAS RETURNED IN SEGMENTS. NO ANOMOLY WAS SEEN IN THE DISPENSING HOLES. NO OCCLUSION WAS SEEN. THERE WAS FOREIGN MATERIAL DEPOSITED ON THE DISTAL END.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THERE WERE NO REASONS DISCOVERED FOR NOT HAVING ANY RETROGRADE FLOW OF CEREBROSPINAL FLUID (CSF) AND INABILITY TO WITHDRAW CSF DURING SURGERY. THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6)-2013 AND THE HCP REPORTED SHE WAS DOING "AWESOME" ON AN INFUSION RATE OF 136 MCG/DAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS SCHEDULED FOR AN EXPECTED END OF LIFE PUMP REPLACEMENT. HOWEVER, WHEN THE CATHETER WAS DISCONNECTED FROM THE PUMP, THERE WAS NO RETROGRADE FLOW OF CEREBROSPINAL FLUID (CSF), NOR WAS THERE THE ABILITY TO WITHDRAW CSF. THE PHYSICIAN USED A 24 GAUGE ANGIO-CATHETER AND 3ML SYRINGE FOR THE ATTEMPTED WITHDRAW. THE CATHETER WAS CONSEQUENTLY REPLACED AS WELL. THE PATIENT WAS SAID TO HAVE NEVER EXHIBITED ANY SIGNS OR SYMPTOMS OF WITHDRAWAL. IT WAS SAID THE PATIENT REQUIRED HOSPITALIZATION, SURGICAL INTERVENTION, REVISION OF THE CATHETER, AND REPROGRAMMING, AS A RESULT OF THE EVENT. THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT. THE PUMP WAS DELIVERING GABLOFEN AT 858 MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322856 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00008 YR Hospitalization| R