BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3249768 · Received July 26, 2013

    Report

    Report Number
    3004209178-2013-12354
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8590-9 LOT# N192357, IMPLANTED: 2009 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4). THE CATHETER WAS RETURNED INCOMPLETE IN SEGMENTS. ANALYSIS OF THE CATHETER NOTED NO SIGNIFICANT ANOMALIES WITH ANY OF THE RETURNED SEGMENTS. ALL SEGMENTS PASSED PATENCY AND PRESSURE TESTING IN THE LAB.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE CAUSE OF THE EVENT WAS THE CATHETER. DRUG EFFECTS WERE UNKNOWN. ON "(B)(6) 2003" AN X-RAY WAS PERFORMED, AND ON (B)(6) 2013 A CT SCAN WAS PERFORMED; RESULTS WERE WITHIN NORMAL LIMITS. ON (B)(6) 2013, A SIDEPORT ASPIRATION WAS DONE AND IT WAS ¿EASILY ASPIRATED.¿ ON (B)(6)2013, A CATHETER DYE STUDY WAS DONE AND THE CATHETER WAS INTACT AND PATENT. A REVISION AND REPLACEMENT OF THE CATHETER WAS PERFORMED. THE PATIENT EXPERIENCED POOR THERAPEUTIC EFFECT OF THE BACLOFEN, AND THE PATIENT REQUIRED HOSPITALIZATION AFTER THE CATHETER REPLACEMENT SURGERY. THE PATIENT RECOVERED WITHOUT SEQUELAE. THERE WERE NO OBVIOUS PROBLEMS FOUND WITH THE CATHETER FUNCTION, BUT BECAUSE THE PATIENT WAS NOT HAVING THERAPEUTIC EFFECT, THE CATHETER HAD BEEN CHANGED OUT IN ITS ENTIRETY. THE PUMP WAS CHECKED AT SURGERY AND IT WAS FOUND TO BE FUNCTIONING WELL, SO THE PUMP WAS NOT CHANGED. POST OPERATIVELY, THE PATIENT WAS REPORTED TO HAVE THERAPEUTIC EFFECT OF ITB (INTRATHECAL BACLOFEN).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT WAS NOT GETTING THERAPEUTIC EFFECT EVEN THOUGH THE CATHETER APPEARED TO WORK, HOWEVER, THE CATHETER WAS EXPLANTED. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA. THIS DEVICE SYSTEM DELIVERED LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350439 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00020 YR Hospitalization| R