BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4182169 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19929
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    September 23, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4). DEVICE EVALUATION SUMMARY: A PORTION OF THE CATHETER WAS RETURNED FOR ANALYSIS. ANALYSIS FOUND ¿CATHETER BODY HOLE CAUSED BY DEEP ABRASION¿.

    Description of Event or Problem · 1

    THE PATIENT HAD FLUID ACCUMULATION IN HIS LOW BACK THAT WAS ASPIRATED BY THE PHYSICIAN WITH RECURRENCE OF FLUID AGAIN. THE PATIENT ALSO HAD LESS THAN 50% THERAPY RELIEF/DECREASED PAIN CONTROL. A DYE STUDY WAS DONE AND A LEAK WAS NOTED NEAR THE SPINE. THERE WAS A BREAK IN THE DISTAL SEGMENT OF THE CATHETER. ON THE DATE OF THIS REPORT, THE CATHETER WAS REVISED. THERE WAS A LEAK NOTED NEAR THE CONNECTOR POINT IN THE PATIENT¿S BACK. THE PORTION OF THE CATHETER WHERE THE LEAK WAS NOTED WAS REMOVED. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE-NO INJURY¿. THE DEVICE SYSTEM WAS DELIVERING MORPHINE AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661783 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention