BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 6337126 · Received February 16, 2017

    Report

    Report Number
    1723170-2017-00370
    Event Type
    Injury
    Date Received
    February 16, 2017
    Date of Event
    March 1, 2012
    Report Date
    July 12, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT IDS AND WEIGHTS WERE PROVIDED BY THE AUTHOR OF THE FOLLOWING ARTICLE: "YAO C, WU J, ZHUANG D, GUO J, JIANG L, QIU T, MAO Y, ZHOU L. PRELIMINARY APPLICATION OF INTRAOPERATIVE MRI MULTIMODAL IMAGE NAVIGATION IN PUNCTURE BIOPSY OF INTRACRANIAL DISEASE. CHIN J NERV MENT DIS, 2012, 38(3): 182-185.(CHINESE)¿ ON JULY 10, 2017. IN THE MENTIONED ARTICLE, ONE PATIENT HAD (B)(6) AND WEIGHT IS (B)(6) KG. ANOTHER PATIENT HAD EPILEPTIC SEIZURE POSTOPERATIVELY, WHOSE ID IS (B)(6), AND WEIGHT IS (B)(6) KG.

    Additional Manufacturer Narrative · 1

    PATIENT IDS AND WEIGHTS WERE NOT PROVIDED BY THE AUTHORS. REPORTED COMPLICATIONS ARE KNOWN INHERENT RISKS OF THIS TYPE OF PROCEDURE. THERE IS NO ALLEGATION OF MALFUNCTION AND THERE HAVE BEEN NO REQUESTS FOR SERVICE FROM THIS USER. THEREFORE, NO SYSTEM EVALUATION REQUIRED.

    Description of Event or Problem · 1

    (B)(4). MEDTRONIC REPRESENTATIVE SUMMARIZED THE RELEVANT INFORMATION BELOW. AUTHORS YAO C, WU J, ZHUANG D, GUO J, JIANG L, QIU T, MAO Y, ZHOU L. TITLE: PRELIMINARY APPLICATION OF INTRAOPERATIVE MRI MULTIMODAL IMAGE NAVIGATION IN PUNCTURE BIOPSY OF INTRACRANIAL DISEASE JOURNAL CHIN J NERV MENT DIS YEAR/VOLUME/PAGES 2012 VOL 38(3) PGS 182-185. ARTICLE NUMBER DOI:10.3969 / J.ISSN.1002-0152.2012.03.010. (B)(6). PATIENTS: 23 PATIENTS. INDICATION: PUNCTURE BIOPSY OF INTRACRANIAL TUMORS. DEVICES USED: STEALTHSTATION I7 (VERBATIM: ¿TRIA I7¿); NAVIGUS SYSTEM. AE: ONE PATIENT HAD HEMATOMA AT THE PUNCTURE SITE > 30 ML, AND CRANIOTOMY WAS REQUIRED. THE PATIENT HAD MUSCLE WEAKNESS ON THE CORRESPONDING SIDE, WHICH RECOVERED AS OF FOLLOW-UP AT 2 MONTHS. ONE PATIENT HAD EPILEPTIC SEIZURE POSTOPERATIVELY. THERE WAS NO STATED ROOT CAUSE AND NO ALLEGATION THE ADVERSE EVENTS WERE CAUSED BY USE OF STEALTHSTATION OR NAVIGUS SYSTEMS. PATIENTS: 12 MALES AND 11 FEMALES. PATIENTS (B)(6), MEAN (40.2 ± 15.8) YEARS. 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 I7. 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
    118845 STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) I7

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention