BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1980937 · Received February 7, 2011

    Report

    Report Number
    2953769-2011-00009
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - FOLLOW-UP WITH PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TWO LEVELS X-STOP PROCEDURE AT LEVELS L3-L5. AN EXPIRED X-STOP DEVICE WAS IMPLANTED IN THE PATIENT AT LEVEL L4/L5. REPORTEDLY, THE PROCEDURE WENT WELL AND WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. PATIENT'S OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-STOP IPD SYSTEM NQO MEDTRONIC SPINE LLC. 2143031

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR