BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 7449317 · Received April 20, 2018

    Report

    Report Number
    1723170-2018-01711
    Event Type
    Injury
    Date Received
    April 20, 2018
    Date of Event
    May 28, 2016
    Report Date
    June 10, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994450968
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER NOT AVAILABLE ON THE ARTICLE. PATIENT AGE AND PATIENT SEX NOT MADE AVAILABLE THE ATTACHED JOURNAL ARTICLE OR BY THE AUTHORS. THE ARTICLE REPORTS THAT THE MEAN PATIENT AGE WAS 57 AND THE CONSISTED OF MALE PATIENTS IN THE STUDY. THEREFORE 57 YEAR OLD AND MALE WERE USED. PATIENT WEIGHT NOT AVAILABLE ON THE ARTICLE. EVENT DATE IS APPROXIMATED. DATE PROVIDED IS WHEN THE JOURNAL ARTICLE WAS ACCEPTED. CITATION: RODOLFO MADURI, LUKAS BOBINSKI, AND JOHN MICHAEL DUFF. IMAGE MERGE TAILORED ACCESS RESECTION (IMTAR) OF SPINAL INTRADURAL TUMORS. TECHNICAL REPORT OF 13 CASES. (2017). WORLD NEUROSURG. (2017) 98:594-602. HTTP://DX.DOI.ORG/10.1016/J.WNEU.2016.05.092. NO PROCODE, COMMON DEVICE NAME AND/OR 510K PROVIDED AS THIS DEVICE IS NOT RELEASED FOR DISTRIBUTION IN THE UNITED STATES. SYSTEM INFORMATION WAS ESTIMATED BASED ON THE ARTICLE INFORMATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INFORMATION PROVIDED IN THE JOURNAL ARTICLE OR FROM THE AUTHORS. THE AUTHOR COULD NOT PROVIDE ANY ADDITIONAL INFORMATION OR INSIGHT AS HE WAS NOT AT THE SITE WHEN THE SURGERIES WERE PERFORMED. NO REQUEST FOR SERVICE HAVE BEEN RECEIVED FROM THE CUSTOMER REGARDING THESE EVENTS. NO PARTS HAVE BEEN REPLACED OR RETURNED TO THE MANUFACTURER FOR EVALUATION. PER THE JOURNAL ARTICLE, THERE WAS NO NEUROLOGICAL DEFICIT OUTSIDE OF THE EXPECTED SENSORY LOSS DUE TO INTENTIONAL NERVE ROOT SACRIFICE. NO MECHANICAL PAIN NOR TUMOR RECURRENCE WERE NOTED DURING THE FOLLOW-UP MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S IMAGING SYSTEM AND SURGICAL NAVIGATION SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NOT RETURNED BY CUSTOMER.

    Additional Manufacturer Narrative · 1

    CORRECTION: UPDATED WITH CORRECT FORMAT FOR LITERATURE REVIEW. CONTAINED INCORRECT STATEMENT. :NO PROCODE, COMMON DEVICE NAME AND/OR 510K PROVIDED AS THIS DEVICE IS NOT RELEASED FOR DISTRIBUTION IN THE UNITED STATES. SYSTEM INFORMATION WAS ESTIMATED BASED ON THE ARTICLE INFORMATION," IN THE INITIAL MDR. THE FIELDS WERE POPULATED WITH THE CORRECT INFORMATION AT THE TIME OF SUBMISSION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE ATTACHED JOURNAL ARTICLE WAS FORWARDED BY MEDTRONIC REPRESENTATIVE. RETROSPECTIVE CHART REVIEW OF 13 CONSECUTIVE PATIENTS (MEAN AGE 57 YEARS; MALE-TO-FEMALE RATIO, 10:3) WERE OPERATED ON DURING 28 MONTHS. GROSS TOTAL RESECTION WAS ACHIEVED IN ALL PATIENTS. NEUROLOGICAL IMPROVEMENT OCCURRED IN 12 OF THE 13 PATIENTS. THERE WAS NO NEUROLOGICAL DEFICIT OUTSIDE OF THE EXPECTED SENSORY LOSS DUE TO INTENTIONAL NERVE ROOT SACRIFICE. NO MECHANICAL PAIN NOR TUMOR RECURRENCE WERE NOTED DURING THE FOLLOW-UP (MEAN, 16 MONTHS; RANGE, 2E30 MONTHS). IMMEDIATE POSTOPERATIVE COURSE MEAN HOSPITAL STAY WAS 8.7 DAYS (RANGE, 3E26 DAYS). ONE PATIENT, A (B)(6) MAN WITH SEVERE MYELOPATHY (NURICK IV) AND A C3-C4 MENINGIOMA HAD AN HOSPITAL STAY OF 26 DAYS AWAITING REHABILITATION PLACEMENT. ONE PATIENT DEVELOPED A SUBCUTANEOUS HEMATOMA AT THE OPERATIVE SITE IN THE IMMEDIATE POSTOPERATIVE PERIOD, WHICH WAS TREATED CONSERVATIVELY AND RESOLVED. ONE PATIENT PRESENTED AN ACUTE CONFUSIONAL STATE RELATED TO POSTOPERATIVE STEROIDS, WHICH RESOLVED RAPIDLY WITH CESSATION OF THE STEROIDS. THERE WAS NO NEUROLOGICAL DEFICIT OUTSIDE THE EXPECTED SENSORY LOSS DUE TO INTENTIONAL NERVE ROOT SACRIFICE. TWO PATIENTS PRESENTED WITH SENSORY LOSS IN THE IMMEDIATE POSTOPERATIVE PERIOD, 1 PATIENT OPERATED ON FOR A T12-L1 SCHWANNOMA AND 1 PATIENT OPERATED ON FOR A L3-L4 SCHWANNOMA. THERE WAS NO POSTOPERATIVE CSF LEAK. CONCLUSION: RESECTION OF IDEM LESIONS REMAINS CHALLENGING. THE PRESENT REPORT DEMONSTRATES A NOVEL APPLICATION OF MERGING OF INTRAOPERATIVE 3D FLUOROSCOPIC IMAGES WITH PREOPERATIVE MRI FOR A GUIDED APPROACH TO THE TARGETED TUMOR. IMTAR FACILITATES TUMOR DISSECTION AND REMOVAL, YET MINIMIZING SURROUNDING SOFT TISSUE DAMAGE AND AVOIDING UNNECESSARY BONE REMOVAL. THESE PRELIMINARY RESULTS ARE ENCOURAGING AND APPEAR TO BE AT LEAST EQUIVALENT TO OTHER TUBULAR TECHNIQUES FOR IDEM RESECTION. THIS INDIVIDUALLY TAILORED APPROACH MINIMIZES PERIOPERATIVE TISSUE DISRUPTION AND BONE RESECTION AND MAY REDUCE THE RISK FOR IATROGENIC INSTABILITY WITHOUT COMPROMISE OF SURGICAL RESECTION. IMTAR MAY ALSO HELP TO DECREASE THE RISK OF WRONG LEVEL SURGERY.

    Description of Event or Problem · 1

    CITATION: RODOLFO MADURI, LUKAS BOBINSKI, JOHN MICHAEL DUFF. IMAGE MERGE TAILORED ACCESS RESECTION (IMTAR) OF SPINAL INTRADURAL TUMORS. TECHNICAL REPORT OF 13 CASES. WORLD NEUROSURG. (2017) 98:594-602. OBJECTIVE: STANDARD TRANSLAMINAR APPROACHES FOR INTRADURAL EXTRAMEDULLARY (IDEM) TUMORS REQUIRE EXTENSIVE SOFT TISSUE DISSECTION AND PARTIAL FACET REMOVAL. VENTRAL LESIONS MAY NECESSITATE WIDER BONE RESECTION WITH SUBSEQUENT POSSIBLE SPINAL INSTABILITY. ANY MANIPULATION OF AN ALREADY COMPROMISED SPINAL CORD MAY LEAD TO NEUROLOGICAL INJURY. WE DESCRIBE AN IMAGE-GUIDED MINIMAL ACCESS TECHNIQUE FOR IDEM TUMOR RESECTION. METHODS: RETROSPECTIVE CHART REVIEW OF 13 CONSECUTIVE PATIENTS (MEAN AGE. 57 YEARS; MALE-TO-FEMALE RATIO, 10:3) WERE OPERATED ON DURING 28 MONTHS. GROSS TOTAL RESECTION WAS ACHIEVED IN ALL PATIENTS. NEUROLOGICAL IMPROVEMENT OCCURRED IN 12 OF THE 13 PATIENTS. THERE WAS NO NEUROLOGICAL DEFICIT OUTSIDE OF THE EXPECTED SENSORY LOSS DUE TO INTENTIONAL NERVE ROOT SACRIFICE. NO MECHANICAL PAIN NOR TUMOR RECURRENCE WERE NOTED DURING THE FOLLOW-UP (MEAN, 16 MONTHS; RANGE, 2E30 MONTHS). IMMEDIATE POSTOPERATIVE COURSE MEAN HOSPITAL STAY WAS 8.7 DAYS (RANGE, 3E26 DAYS). ONE PATIENT, A (B)(6) YEAR-OLD MAN WITH SEVERE MYELOPATHY (NURICK IV) AND A C3-C4 MENINGIOMA HAD AN HOSPITAL STAY OF 26 DAYS AWAITING REHABILITATION PLACEMENT. ONE PATIENT DEVELOPED A SUBCUTANEOUS HEMATOMA AT THE OPERATIVE SITE IN THE IMMEDIATE POSTOPERATIVE PERIOD, WHICH WAS TREATED CONSERVATIVELY AND RESOLVED. ONE PATIENT PRESENTED AN ACUTE CONFUSIONAL STATE RELATED TO POSTOPERATIVE STEROIDS, WHICH RESOLVED RAPIDLY WITH CESSATION OF THE STEROIDS. THERE WAS NO NEUROLOGICAL DEFICIT OUTSIDE THE EXPECTED SENSORY LOSS DUE TO INTENTIONAL NERVE ROOT SACRIFICE. TWO PATIENTS PRESENTED WITH SENSORY LOSS IN THE IMMEDIATE POSTOPERATIVE PERIOD, 1 PATIENT OPERATED ON FOR A T12-L1 SCHWANNOMA AND 1 PATIENT OPERATED ON FOR A L3-L4 SCHWANNOMA. THERE WAS NO POSTOPERATIVE CSF LEAK. CONCLUSION: RESECTION OF IDEM LESIONS REMAINS CHALLENGING. THE PRESENT REPORT DEMONSTRATES A NOVEL APPLICATION OF MERGING OF INTRAOPERATIVE 3D FLUOROSCOPIC IMAGES WITH PREOPERATIVE MRI FOR A GUIDED APPROACH TO THE TARGETED TUMOR. IMTAR FACILITATES TUMOR DISSECTION AND REMOVAL, YET MINIMIZING SURROUNDING SOFT TISSUE DAMAGE AND AVOIDING UNNECESSARY BONE REMOVAL. THESE PRELIMINARY RESULTS ARE ENCOURAGING AND APPEAR TO BE AT LEAST EQUIVALENT TO OTHER TUBULAR TECHNIQUES FOR IDEM RESECTION. THIS INDIVIDUALLY TAILORED APPROACH MINIMIZES PERIOPERATIVE TISSUE DISRUPTION AND BONE RESECTION AND MAY REDUCE THE RISK FOR IATROGENIC INSTABILITY WITHOUT COMPROMISE OF SURGICAL RESECTION. IMTAR MAY ALSO HELP TO DECREASE THE RISK OF WRONG LEVEL SURGERY. REPORTED EVENTS: (B)(6) Y/O F WITH T10-T11 MENINGIOMA WITH FOLLOW UP RESULTS OF RADICULAR SENSORY LOSS. (B)(6) Y/O F WITH C2 NEUROFIBROMA WITH FOLLOW UP RESULTS OF RADICULAR SENSORY LOSS. (B)(6) Y/O M WITH T12-L1 SCHWANNOMA WITH FOLLOW UP RESULTS OF RADICULAR SENSORY LOSS AND DYESTHESIA. (B)(6) Y/O M WITH L3-L4 SCHWANNOMA WITH FOLLOW UP RESULTS OF RADICULAR SENSORY LOSS AND DYESTHESIA. (B)(6) Y/O M WITH SEVERE MYELOPATHY (NURICK IV) AND C3-C4 MENINGIOMA HAD A HOSPITAL STAY OF 26 DAYS WAITING REHAB PLACEMENT. 1 PATIENT DEVELOPED A SUBCUTANEOUS HEMATOMA AT THE OPERATIVE SITE IN THE IMMEDIATE POSTOPERATIVE PERIOD, WHICH WAS TREATED CONSERVATIVELY AND RESOLVED. (B)(6) Y/O M WITH T12-L1 SCHWANNOMA PRESENTED WITH SENSORY LOSS IN THE IMMEDIATE POSTOPERATIVE PERIOD. (B)(6) Y/O M WITH L3-L4 SCHWANNOMA PRESENTED WITH SENSORY LOSS IN THE IMMEDIATE POSTOPERATIVE PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291111 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 00613994450968

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| O| S