BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1902439 · Received October 22, 2010

    Report

    Report Number
    2953769-2010-00559
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    October 21, 2008
    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 Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - DEVICE WAS NOT RETURNED; FOLLOWED UP WITH COMPANY REP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6), PATIENT UNDERWENT AN X-STOP PROCEDURE. TWELVE DAYS POST IMPLANT, THE PATIENT EXPERIENCED NUMBNESS ON BOTTOMS OF BOTH FEET AT BEDTIME. 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 UNK Other