BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7

    MDR report key: 10288718 · Received July 17, 2020

    Report

    Report Number
    1723170-2020-01947
    Event Type
    Injury
    Date Received
    July 17, 2020
    Date of Event
    March 2, 2019
    Report Date
    July 17, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. PATIENT GENDER IS THE MAJORITY VALUE OF THE PATIENT IN THE STUDY. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: JOSÉ M. GONZÁLEZ-DARDER, PAU CAPILLA-GUASCH, LUIS REAL-PEÑA. RETROSIGMOID APPROACH: A SIMPLE AND SAFE WAY TO RESECT INTRINSIC PONTOMEDULLARY LESIONS. J NEUROL SURG B 2020;81:223¿231. HTTPS://DOI.ORG/10.1055/S-0039-1685536. ISSN (B)(4). OBJECTIVES: THE MAIN OBJECTIVE OF THIS ARTICLE IS TO DESCRIBE A SIMPLE AND SAFE PROTOCOL FOR THE MICROSURGICAL MANAGEMENT OF VENTRALLY LOCATED INTRINSIC PONTOMEDULLARY LESIONS BASED ON THE RETROSIGMOID APPROACH, CORTECTOMY PERFORMED UTILIZING SAFE ENTRY ZONES OF THE PONS AND MEDULLA, AND A DELICATE MICROSURGICAL RESECTION. THE INTRAOPERATIVE PROTOCOL INCLUDES REDUNDANT PROCEDURES THAT PROVIDE SECURITY IN DECISION-MAKING DURING SURGERY. DESIGN: A PROSPECTIVE SERIES OF 11 CASES IS PRESENTED. ALL PATIENTS WERE STUDIED FOLLOWING THE SAME CLINICAL AND IMAGING WORKUP. A REGULAR RETROSIGMOID CRANIOTOMY SURGICAL APPROACH WAS UTILIZED. THE PERITRIGEMINAL AREA IN THE PONS AND THE OLIVARY AREA IN THE MEDULLA WERE CONSIDERED AS THE SAFE ENTRY ZONES. NEURONAVIGATION OF THE WHITE FIBER TRACTS AND ELECTROPHYSIOLOGICAL MONITORING WERE USED AS INTRAOPERATIVE AIDS TO LOCATE THE LESIONS, THE SAFE ENTRY ZONES, AND THE PLACEMENT OF THE CORTECTOMY. RESULTS: SIX LESIONS WERE PONTINE, TWO MEDULLARY, AND THE REMAINING SIX PONTOMEDULLARY. EIGHT LESIONS WERE CAVERNOMAS, WHILE THE REMAINING THREE TUMORS. OVERALL, WE OBTAINED A POSTOPERATIVE FUNCTIONAL IMPROVEMENT IN THE AFFECTED CRANIAL NERVES IN 90.1% OF THE PATIENTS AND A TOTAL OR PARTIAL RECOVERY OF LONG ASCENDING OR DESCENDING PATHWAY SYMPTOMS IN 72.3% OF THE PATIENTS. ALL THE PATIENTS WERE SATISFIED WITH THE PROCEDURE AND THE RESULTS. CONCLUSIONS: RADICAL RESECTION OF VENTRAL INTRINSIC PONTOMEDULLARY LESIONS DISPLAYS A HIGH DEGREE OF INTRAOPERATIVE RELIABILITY, AND A GOOD CLINICAL RESULT IS POSSIBLE USING SIMPLE SURGICAL PROCEDURES. THE ANATOMICAL REFERENCES ARE THE FIRST ELEMENT IN THE DECISION-MAKING PROCESS DURING SURGERY. REPORTED EVENTS: TWO PATIENTS EXPERIENCED A TRANSIENT CEREBROSPINAL FLUID (CSF) LEAK IN THE IMMEDIATE POST-OPERATIVE PERIOD THAT WAS RESOLVED THROUGH REINFORCEMENT POINTS. (B)(6) YR MALE PATIENT EXPERIENCED A TRANSIENT POST-OPERATIVE SIXTH NERVE PARESIS (B)(6) YR FEMALE PATIENT EXPERIENCED LATE RE-BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755454 STEALTHSTATION S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733858

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention