BEUDAMED
    FDA Adverse Event Other Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1439818 · Received August 13, 2009

    Report

    Report Number
    2953769-2009-00106
    Event Type
    Other
    Date Received
    August 13, 2009
    Date of Event
    July 16, 2009
    Report Date
    July 15, 2009
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG NUMBER: 1-3214. ADDITIONAL LOT NUMBER: 2081451. METHOD - DEVICE NOT RETURNED FOR EVALUATION; FOLLOW UP WITH COMPANY REPRESENTATIVE. EXPIRATION DATE FOR LOT # 2081451 = 10/31/2009. MANUFACTURE DATE FOR LOT # 2081451 = 10/2007.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD NEUROLOGIC CLAUDICATION WITH INCREASING SYMPTOMS FOR ABOUT FOUR YEARS AND HAD AN X-STOP PROCEDURE AT LEVELS L3/L4 AND L4/L5 ON (B) (6) 2008 AS PART OF A POST-MARKETING STUDY. THE PATIENT EXPERIENCED INITIAL RELIEF FOLLOWING THE X-STOP PROCEDURE AND THEN DEVELOPED RECURRENCE AND PROGRESSION OF SYMPTOMS. THE PATIENT HAS HAD THREE LUMBAR EPIDURALS WITH TEMPORARY AND PARTIAL RELIEF. RADIOGRAPHS SHOWED THE X-STOP IMPLANTS REMAIN IN PLACE. A CT MYELOGRAM SHOWED A PROBABLE FRACTURE OF THE SPINOUS PROCESS WITH RESIDUAL MODERATE STENOSIS AT L3-4 AND 4-5, AND MILD TO MODERATE STENOSIS AT L2-3. THE PT ALSO HAS A SEVERE DEGENERATIVE DISK AT L1-2. DECOMPRESSIVE LAMINECTOMIES WERE PERFORMED AT L2-3, 3-4 AND 4-5 WITH REMOVAL OF THE X-STOP DEVICES AT L3-4 AND 4-5. THE PATIENT'S STATUS AFTER THE PROCEDURES WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-STOP IPD SYSTEM INTERSPINOUS PROCESS SPACER NQO MEDTRONIC SPINE LLC X-STOP PEEK 2073851

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other| R