BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NQO

    MDR report key: 2048422 · Received April 11, 2011

    Report

    Report Number
    2953769-2011-00041
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 16, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENTS REPORTED FOR THE EIGHT PATIENTS WITH X-STOP DEVICES IMPLANTED ARE REPORTED IN MFR REPORT # 2953769-2011-00041 TO 2953769-2011-00048. REPORT SOURCE: ARTICLE TITLED "CRITICAL ANALYSIS OF LUMBAR INTERSPINOUS DEVICES FAILURES: A RETROSPECTIVE STUDY", BY FRANCESCO CIRO TAMBURRELLI, LUCA PROIETTI, CARLO AMBROGIO LOGROSCINO. EVAL METHOD: FOLLOW-UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "CRITICAL ANALYSIS OF LUMBAR INTERSPINOUS DEVICES FAILURES: A RETROSPECTIVE STUDY", A RETROSPECTIVE REVIEW WAS PERFORMED ON PATIENTS WITH A RESIDUAL PAINFUL SYNDROME AFTER IMPLANTATION OF INTERSPINOUS DEVICES. THE INCLUSION CRITERIA WERE LOW BACK PAIN AND/OR RADICULOPATHY AFTER THE DEVICE IMPLANTATION WITHOUT IMPROVEMENT OF THE PAINFUL SYMPTOMATOLOGY, RADICULOPATHY WITH SIGNS OF SENSORY AND MOTOR DEFICIT, INTERMITTENT NEUROGENIC CLAUDICATION, AND INFECTION. FROM (B)(6) 2007 TO (B)(6) 2009, THE SERIES INCLUDES 11 MALES AND 8 FEMALES WITH A MEAN AGE OF (B)(6). THE FOLLOWING WAS REPORTED FOR PATIENT 1 OF 8 PATIENTS WITH X-STOP DEVICES IMPLANTED. THE PATIENT UNDERWENT X-STOP PROCEDURES AT LEVELS L3-L4 AND L4-L5. PATIENT WAS AFFECTED BY A SEVERE NEUROGENIC CLAUDICATION THAT DID NOT IMPROVE AFTER THE PROCEDURE. PATIENT UNDERWENT DEVICE REMOVAL AND DECOMPRESSIVE LAMINECTOMY WITHOUT STABILISATION WITH A SATISFACTORY IMPROVEMENT OF THE WALKING CAPACITY. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NQO NQO MEDTRONIC SPINE LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Other