BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1902464 · Received October 22, 2010

    Report

    Report Number
    2953769-2010-00566
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    October 22, 2006
    Report Date
    September 23, 2010
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE WAS NOT RETURNED; FOLLOWED UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6), PATIENT UNDERWENT AN X-STOP PROCEDURE. THE PATIENT WAS NOTED WITH NEW AND/OR WORSENING LSS SYMPTOMS AT THE IMPLANTED LEVELS, L4/L5 AND L5/S1. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other