BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4182225 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19908
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    September 25, 2014
    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

    PRODUCT ID 8835, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE CATHETER. (B)(6).

    Description of Event or Problem · 1

    A CATHETER BREAK WAS REPORTED. FLUOROSCOPY SHOWED A CATHETER MIGRATION; THE CATHETER WAS NO LONGER IN CONTINUITY WITH THE INTRATHECAL COMPARTMENT AND APPEARED TO BE OCCLUDED/OBSTRUCTED. THE PATIENT EXPERIENCED A BURNING SENSATION INVOLVING THEIR ENTIRE BACK AND A "CHILLED" FEELING. THE PATIENT WAS GIVEN NORCO AND ZANAFLEX FOR PREVENTION OF WITHDRAWAL SYMPTOMS. DURING THE CATHETER REVISION THE CATHETER WAS FOUND TO BE KINKED AND BROKEN WITH AN APPARENT FREE INTRATHECAL FRAGMENT. THE CATHETER WAS SPLICED AND THE ISSUE RESOLVED WITHOUT SEQUELA. THE PUMP DELIVERED MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661576 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention