BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3365835 · Received September 24, 2013

    Report

    Report Number
    1723170-2013-00742
    Event Type
    Injury
    Date Received
    September 24, 2013
    Date of Event
    August 26, 2013
    Report Date
    August 26, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED AFTER FURTHER INVESTIGATION THAT THE SITE'S NEW CERETOM SCANNER PRODUCED EXAMS THAT WERE VOLUMETRICALLY DIFFERENT FROM THE DIAGNOSTIC CT EXAM. ANALYSIS OF THE SCANS USED FOUND THAT MEASUREMENTS BETWEEN PEGS VARY FROM CERETOM SCAN TO CERETOM SCAN AND ARE OFF BY ABOUT 2 MM FROM THE ACTUAL MEASUREMENTS. DISCREPANCY BETWEEN THE SCANNER FLOORS CAUSED THE REPORTED EVENT. THE SITE HAS BEEN NOTIFIED OF THE DISCREPANCY. MEDTRONIC NAVIGATION, INC. SOFTWARE IS FUNCTIONING AS DESIGNED.

    Additional Manufacturer Narrative · 1

    THE SITE HAS INSTALLED A NEW FLOOR IN THE OPERATING ROOM TO REMOVE THE IMAGE DISCREPANCIES AND VOLUMETRIC DIFFERENCES IN THE CERETOM SCANS. THE SITE HASN'T HAD ANY PROBLEMS SINCE.

    Additional Manufacturer Narrative · 1

    THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FROM THE SITE.SOFTWARE INVESTIGATION NOT COMPLETED AT TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, AGE, AND SEX PROVIDED. WEIGHT WAS UNAVAILABLE FROM THE SITE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE, REPORTED THAT WHILE IN A DEEP BRAIN STIMULATION (DBS) PROCEDURE, THE STEALTHMERGE BETWEEN THE 1.5T PRE-OP MRI AND THE INTRA-OP CT WAS 'OFF'. THE MRI LOOKED VOLUMETRICALLY SMALLER THAN THE CT. REGISTERING USING POINTMERGE AND USING NEXFRAME, THE IMAGES WERE 4MM OFF ANTERIORLY. THE SITE DID NOT LOOK AT ACPC ON THE CT ONLY THE MR. THEY PLACED TWO LEADS AND THEN TOOK ANOTHER IMAGE; THE LEADS WERE OFF BY 4MM. RE-PLANNED BASED ON THE CT AND REPLACED THE TWO LEADS; THEN WERE 2MM OFF. THE SURGEON LEFT THE LEADS IN THIS LOCATION TO COMPLETE THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. ALTHOUGH THERE WERE LEAD REVISIONS REQUIRED TO PREVENT IMPACT TO THE PATIENT DUE TO AN INACCURATE MERGE USED DURING THERAPY DELIVERY, THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482361 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR