BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2892069 · Received January 2, 2013

    Report

    Report Number
    3004209178-2013-00004
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    December 3, 2012
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL 8731SC, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHOLE SYSTEM WAS REMOVED. IT WAS ADDED THAT THE CATHETER CAME OUT OF THE INTRATHECAL SPACE AND "WAS NO LONGER PATENT". THE DEVICE WAS DISCARDED. IN REGARDS TO THE DISLODGEMENT IT WAS STATED THAT IT WAS DETECTED AT THE TIME OF REMOVAL AND NO TROUBLESHOOTING WAS DONE PRIOR TO SYSTEM REMOVAL. IT WAS STATED THAT PATIENT HAD NO PAIN RELIEF. FOLLOWING SYSTEM EXPLANT PATIENT WAS INDICATED TO BE DOING WELL. DRUG DELIVERED VIA THE DEVICE WAS MORPHINE 5MG/ML, 1.5MG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention