BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 3852235 · Received June 5, 2014

    Report

    Report Number
    1723170-2014-00554
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    December 1, 2009
    Report Date
    December 22, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER AND WEIGHT WERE NOT AVAILABLE. PER THE LITERATURE ARTICLE, FROM (B)(6) 2009 TO (B)(6) 2010, 14 PATIENTS AND 16 LEVELS WERE OPERATED. THE SERIES COMPRISED 13 MEN AND 1 WOMAN WHOSE MEAN AGE WAS 49.8 YEARS (RANGE: 37-67 YEARS). NO KNOWN DEVICE PROBLEM. THERE IS NO ALLEGATION OF A PROBLEM WITH THE MEDTRONIC PRODUCT. INITIAL REPORTER IS A REGISTERED NURSE (RN) AND A MEDTRONIC REPRESENTATIVE. EVENT SITE IS LOCATED IN (B)(6). NO EVALUATION PERFORMED AS THERE IS NO ALLEGATION THAT THE NAVIGATION SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AUTHORS CONCLUDED: POSTERIOR CERVICAL MICROFORAMINOTOMY ASSISTED BY O-ARM-BASED NAVIGATION IS A SAFE, EFFECTIVE AND MINIMALLY INVASIVE PROCEDURE FOR THE TREATMENT OF LATERAL DISC HERNIATIONS AND FORAMINAL STENOSIS OF THE LOWER CERVICAL SPINE AND C-T JUNCTION, OFFERING THE ADVANTAGE OF AN ACCURATE DECOMPRESSION TOGETHER WITH A REDUCED RISK OF SEGMENTAL INSTABILITY. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    CORRECTION: SERIAL NUMBER AND DEVICE MANUFACTURE DATE PROVIDED.

    Description of Event or Problem · 1

    CERVICAJOURNAL ARTICLE: MINIMALLY INVASIVE POSTERIOR CERVICAL MICROFORAMINOTOMY IN THE LOWER CERVICAL SPINE AND C-T JUNCTION ASSISTED BY O-ARM-BASED NAVIGATION BY DAVID DEL CURTO, JIN-SUNG KIM, & SANG-HO LEE. BETWEEN (B)(6) 2009 AND (B)(6) 2010, 14 PATIENTS WITH UNILATERAL FORAMINAL DISC HERNIATIONS OR FORAMINAL STENOSIS AT THE C6-7 OR C7-T1 LEVEL UNDERWENT POSTERIOR CERVICAL MICROFORAMINOTOMY (PCM) ASSISTED BY O-ARM NAVIGATION. THERE WERE NO CASES OF INSTABILITY OR RECURRENCE, AND THE ONLY COMPLICATION OBSERVED WAS A DURAL TEAR IN ONE PATIENT, WHICH WAS ADEQUATELY TREATED WITH FIBRIN GLUE AND BED REST. SUCCESSFUL RELIEF OF RADICULAR PAIN WAS ACHIEVED IN ALL PATIENTS. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330141 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention