BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLESTAR INTEGRATION SYSTEM

    MDR report key: 5746668 · Received June 23, 2016

    Report

    Report Number
    1723170-2016-01226
    Event Type
    Injury
    Date Received
    June 23, 2016
    Date of Event
    August 24, 2011
    Report Date
    June 23, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS NOT PROVIDED IN THE ARTICLE, BUT WAS REQUESTED FROM THE SURGEON VIA EMAIL. SENFT C, BINK A, FRANZ K, VATTER H, GASSER T, SEIFERT V. INTRAOPERATIVE MRI GUIDANCE AND EXTENT OF RESECTION IN GLIOMA SURGERY: A RANDOMISED, CONTROLLED TRIAL. LANCET ONCOLOGY. 2011; 12: 997¿1003. DOI:10.1016/S1470- 2045(11)70196-6. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NEUROLOGICAL DEFICITS AND REBLEEDING ARE KNOWN INHERENT RISKS TO CRANIAL RESECTION SURGERY. ARTICLE CONCLUDES THE FOLLOWING: INTRAOPERATIVE IMAGING LED TO CONTINUED RESECTION OF CONTRAST ENHANCING TISSUE IN A THIRD OF PATIENTS IN THE INTRAOPERATIVE MRI GROUP. HAD INTRAOPERATIVE IMAGING NOT BEEN USED, THE RESECTION RATES BETWEEN TREATMENT GROUPS WOULD NO LONGER DIFFER SIGNIFICANTLY. THE BENEFICIAL EFFECT OF INTRAOPERATIVE MRI IS PROBABLY DUE TO THE ABILITY TO REASSESS NEURONAVIGATION DURING SURGERY. NEURONAVIGATION IS USUALLY BASED UPON PREOPERATIVE IMAGING, AND ANATOMY IS ALTERED DURING SURGERY DUE TO RESECTION OF TISSUE AND LOSS OF CEREBROSPINAL FLUID. THESE ALTERATIONS, SO-CALLED BRAIN-SHIFT, RENDER CONVENTIONAL NEURONAVIGATION SOMEWHAT INACCURATE AFTER DURA OPENING AND DURING TUMOUR RESECTION. THEREFORE, TUMOUR REMNANTS CAN BE OVERLOOKED. INTRAOPERATIVE IMAGING CAN BE USED TO DEPICT THESE REMNANTS, AND RESTORE THE ACCURACY OF NEURONAVIGATION. IN THIS STUDY, EXTENT OF RESECTION IN THE INTRAOPERATIVE MRI GROUP WAS BETTER THAN IT WAS IN THE CONTROL GROUP EVEN AFTER EXCLUSION OF SURGERIES DONE WITHOUT THE USE OF A NEURONAVIGATION SYSTEM. IMPORTANTLY, OUR DATA SHOW THAT THIS ENHANCED RESECTION WAS NOT ACHIEVED AT THE COST OF INCREASED SURGICAL MORBIDITY. THE OVERALL COMPLICATION RATE IN THIS STUDY WAS WITHIN PREVIOUSLY REPORTED LIMITS, AND COMPLICATIONS DID NOT OCCUR IN PATIENTS IN WHOM INTRAOPERATIVE MRI LED TO CONTINUED RESECTION OF TUMOUR TISSUE. USE OF INTRAOPERATIVE MRI THUS IMPROVES THE NEUROSURGEON¿S GOAL OF EXTENSIVE BUT SAFE TUMOUR RESECTION.

    Description of Event or Problem · 1

    PER ATTACHED ARTICLE, LISTED IN TABLE 3, PATIENT 31 OF THE INTRAOPERATIVE MRI GROUP, WHO UNDERWENT RESECTION FOR LEFT TEMPORAL GLIOBLASTOMA HAD 0% RESIDUAL TUMOR, BUT HAD POSTOPERATIVE REBLEEDING AND APHASIA. NO ALLEGATION OF MEDTRONIC PRODUCT DEFICIENCY. FOUR ADDITIONAL MDRS (, 1723170-2016-01223, 1723170-2016-01224, 1723170-2016-01225, 1723170-2016-01227) WILL BE SUBMITTED FOR THE OTHER 4 PATIENTS SPECIFICALLY MENTIONED IN TABLE 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400623 POLESTAR INTEGRATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) POLESTAR

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R| S