BEUDAMED
    FDA Adverse Event Death Summary report: N

    STEALTHSTATION S7

    MDR report key: 11630935 · Received April 7, 2021

    Report

    Report Number
    1723170-2021-00919
    Event Type
    Death
    Date Received
    April 7, 2021
    Date of Event
    December 20, 2020
    Report Date
    April 7, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THE DEATH DATE OF THE 2 PATIENTS IS UNKNOWN. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE WHEN THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. THE UNIQUE IDENTIFIER WAS NOT KNOWN AT THE TIME OF REPORTING. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. THE MANUFACTURE DATE WAS NOT KNOWN AT THE TIME OF REPORTING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    HALL, S., KABWAMA, S., SADEK, A.R., DANDO, A., ROACH, J., WEIDMANN, C., GRUNDY, P., AWAKE CRANIOTOMY FOR TUMOUR RESECTION: THE SAFETY AND FEASIBILITY OF A SIMPLE TECHNIQUE. INTERDISCIPLINARY NEUROSURGERY: ADVANCED TECHNIQUES AND CASE MANAGEMENT. 2021 24 (1-6). HT TPS://DOI.ORG/10.1016/J.INAT.2020.101070 INTRODUCTION: AWAKE CRANIOTOMY IS WIDELY USED FOR SURGERY IN ELOQUENT BRAIN IN ORDER TO FACILITATE MAXIMAL SAFE RESECTION OF BRAIN TUMOURS. THERE HAS BEEN HUGE PROGRESS IN BOTH SURGICAL AND ANAESTHETIC TECHNIQUES USED DURING AWAKE CRANIOTOMY. THIS STUDY REPORTS A SINGLE SURGEON EXPERIENCE OF AWAKE CRANIOTOMY FOR TUMOUR RESECTION OVER A 14 YEAR PERIOD FOCUSING ON THE SAFETY AND FEASIBILITY OF A SIMPLE TECHNIQUE. METHODS: PATIENTS WHO UNDERWENT AWAKE CRANIOTOMY FOR TUMOUR RESECTION BETWEEN 2006 AND 2019 (INCLUSIVE) WERE IDENTIFIED RETROSPECTIVELY FROM THEATRE LOGBOOKS IN AN NHS NEUROSCIENCES CENTRE. CASE NOTE REVIEW WAS PERFORMED TO COLLECT DATA ON DEMOGRAPHICS, HISTOLOGY, INTRA-OPERATIVE MAPPING AND COMPLICATIONS. RESULTS: FOUR HUNDRED AND SIXTY-NINE PATIENTS WERE INCLUDED WITH A MEAN AGE OF 52.0 ± 14.3 YEARS. THREE HUNDRED AND SEVENTY-SEVEN (80.2%) OF THE TUMOURS WERE PRIMARY TUMOURS OF WHICH WHO GRADE IV WERE THE MOST COMMON (N = 204, 54.1%). NINETY-TWO (19.6%) OF THE TUMOURS WERE METASTASES WITH BREAST (N = 23, 25.0%), SKIN (N = 22, 23.91%) AND LUNG (N = 22, 23.9%) BEING THE MOST COMMON PRIMARY MALIGNANCIES. THE FRONTAL LOBE WAS THE MOST COMMON LOCATION (N = 221, 47.1%). THE MEDIAN LENGTH OF STAY WAS 1 DAY. ONE HUNDRED AND SEVEN (22.8%) PATIENTS HAD COMPLICATIONS WITH NEUROLOGICAL DEFICITS (N = 73, 15.6%), BEING THE MOST COMMON HOWEVER ONLY 8 PATIENTS (1.7%) HAD PERMANENT NEUROLOGICAL DEFICITS. DISCUSSION: THIS IS THE LARGEST PUBLISHED UK SERIES OF AWAKE CRANIOTOMY FOR TUMOUR RESECTION. IT DEMONSTRATES THE SAFETY AND FEASIBILITY OF A SIMPLE AND EASILY REPRODUCIBLE TECHNIQUE WITH A LOW INCIDENCE OF PERMANENT NEUROLOGICAL DEFICITS AND SHORT DURATIONS OF HOSPITAL ADMISSION. REPORTED EVENTS 2 PATIENTS DIED WITHIN 30 DAYS OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523081 STEALTHSTATION S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733858

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death