BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2771977 · Received October 4, 2012

    Report

    Report Number
    3004209178-2012-08876
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 13, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. ONLY THE CATHETER WAS RETURNED FOR ANALYSIS. ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL ANALYSIS OF THE CATHETER FOUND ACCEPTABLE TESTING. ONLY A PORTION OF THE DISTAL SEGMENT WAS RECEIVED FOR ANALYSIS. AS RECEIVED, THERE WAS NO TISSUE OR OTHER FOREIGN MATERIAL ATTACHED TO THE DISTAL TIP. THE DISPENSING HOLES WERE UN-OCCLUDED AS RECEIVED. THE CATHETER SEGMENT WAS PATENT AS RECEIVED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS REPLACED DUE TO AN INFLAMMATORY MASS THAT DEVELOPED AT THE CATHETER TIP. THE PATIENT BEGAN EXPERIENCING NUMBNESS DOWN THE LEG. AN MRI CONFIRMED THE INFLAMMATORY MASS COVERING APPROXIMATELY 1 VERTEBRAL BODY AT T9. THE PHYSICIAN REMOVED THE EXISTING CATHETER AND REPLACED IT WITH A NEW CATHETER BELOW THE INFLAMMATORY MASS. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS NO INJURY OR ADVERSE EVENT. THE DEVICE SYSTEM WAS USED TO DELIVER INFUMORPH AND BACLOFEN. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Other| R