BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1577914 · Received December 31, 2009

    Report

    Report Number
    2953769-2009-00208
    Event Type
    Injury
    Date Received
    December 31, 2009
    Report Date
    April 23, 2007
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED, FOLLOW UP CONVERSATION WITH COMPANY REPRESENTATIVE. ADDITIONAL LOT NUMBER: 070207.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN IMPLANTED TWO X-STOP DEVICES INTO A PT AT LEVELS L3-4 AND L4-5. AFTER TURNING THE PT TO A SUPINE POSITION, THE PATIENT "CODED". CPR WAS PERFORMED AND THE PT WAS SUCCESSFULLY RESUSCITATED. THE PT WAS SEEN IMMEDIATELY BY A CARDIOLOGIST. REPORTEDLY, THE "PATIENT IS DOING FINE." 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 12MM - X-STOP 070104

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| O