BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 6013241 · Received October 9, 2016

    Report

    Report Number
    1723170-2016-02503
    Event Type
    Injury
    Date Received
    October 9, 2016
    Date of Event
    June 25, 2015
    Report Date
    October 9, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT REPORTED AS (B)(6) 2015 AS EXACT DATE IS NOT SPECIFICALLY DOCUMENTED IN JOURNAL ARTICLE. CITATION: LEE DJ, KIM SUNG-BUM, ROSENTHAL PHILIP, PANCHAL RIPUL R., KIM KEE D. STEREOTACTIC GUIDANCE FOR NAVIGATED PERCUTANEOUS SACROILIAC JOINT FUSION. THE JOURNAL OF BIOMEDICAL RESEARCH, 2016, 30(2):162-167 ON-LINE AT WWW.JBR-PUB.ORG. ARTICLE CONCLUSION: NAVIGATED PERCUTANEOUS SACROILIAC JOINT FUSION INTEGRATING THE IMAGING SYSTEM ALLOWS FOR REAL-TIME NAVIGATION WITH THE ABILITY TO CHECK THE IMPLANT POSITION BEFORE LEAVING THE OPERATING ROOM. THERE WAS NO ALLEGATION OF MALFUNCTION OF THE MEDTRONIC DEVICE. 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 S7 SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    JOURNAL ARTICLE REVIEW: STEREOTACTIC GUIDANCE FOR NAVIGATED PERCUTANEOUS SACROILIAC JOINT FUSION ILLUSTRATIVE CASE 2: A (B)(6) YEAR-OLD MAN WITH A HISTORY OF MORBID OBESITY (BMI OF (B)(6)) PRESENTED WITH LOWER BACK PAIN AND LEFT HIP PAIN. THE PATIENT HAD UNDERGONE A DIAGNOSTIC LEFT SACROILIAC JOINT (SIJ) INJECTION THAT TEMPORARILY RELIEVED 80% OF HIS PAIN. WE THEN PERFORMED IMAGE-GUIDED PLACEMENT OF 2 THREADED CAGES PERPENDICULAR TO THE SIJ (FIG. 4 A,B). AFTER SURGERY, THE PATIENT REPORTED RESOLUTION OF PRE-OPERATIVE PAIN, HOWEVER, NEW SHARP LEFT LEG PAIN. A POST-OPERATIVE LUMBAR COMPUTED TOMOGRAPHY (CT) DEMONSTRATED THAT THE CAGES HAD BREACHED THE VENTRAL CORTICAL WALL OF THE SACRUM (FIG. 4C). WHEN THE PATIENT'S NEW LEFT LEG PAIN DID NOT IMPROVE, HE WAS TAKEN BACK TO THE OPERATING ROOM (OR) FOR CAGE REVISION. USING THE CAGE DRIVER, THE CAGES WERE BACKED OUT SLIGHTLY (FIG. 4D). IMMEDIATELY AFTERWARDS, THE PATIENT REPORTED THAT HIS LEFT LEG PAIN HAD RESOLVED, BUT HE DID NOTE RESIDUAL NUMBNESS THAT GRADUALLY IMPROVED. 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 S7 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
    664372 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention (B)(4) PEAAM