BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 11979435 · Received June 10, 2021

    Report

    Report Number
    1723170-2021-01549
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    February 13, 2021
    Report Date
    June 10, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) 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

    SOP, F.Y.L.; D¿ERCOLE, M., IZZO, A., RAPISARDA, A., IOANNONI, E., CARICATO, A., OLIVI, A., MONTANO, N. THE IMPACT OF NEURONAVIGATION ON THE SURGICAL OUTCOME OF MICROVASCULAR DECOMPRESSION FOR TRIGEMINAL NEURALGIA. WORLD NEUROSURGERY. 2021 149:80-85. DOI.ORG/10.101 6/J.WNEU.2021.02.063 - OBJECTIVE: MICROVASCULAR DECOMPRESSION (MVD) IS CONSIDERED THE ONLY ETIOLOGICAL TREATMENT FOR DRUG-RESISTANT TRIGEMINAL NEURALGIA (TN). NONETHELESS, DESPITE THE RECENT TECHNOLOGICAL ADVANCES, THE RISKS ASSOCIATED WITH MVD REMAIN NON-NEGLIGIBLE. THE AIM OF THIS STUDY WAS TO EVALUATE THE IMPACT OF USING NEURONAVIGATION ON THE SURGICAL OUTCOMES OF PATIENTS WITH TN SUBMITTED FOR MVD. - METHODS: WE ANALYZED 30 CONSECUTIVE PATIENTS (11 MEN, 19 WOMEN) WHO UNDERWENT MVD FOR TN BETWEEN JANUARY 2019 AND DECEMBER 2019. PATIENTS WERE DIVIDED IN 2 GROUPS ACCORDING TO THE USE OF NEURONAVIGATION (GROUP A: MVD WITH NEURONAVIGATION; GROUP B: MVD WITHOUT NEURONAVIGATION). THE IMPACT OF NEURONAVIGATION WAS ASSESSED ON THE FOLLOWING PARAMETERS: CRANIOTOMY SIZE, SURGICAL DURATION, MASTOID AIR CELL OPENING, POSTOPERATIVE CEREBROSPINAL FLUID (CSF) LEAKAGE AND OTHER COMPLICATIONS OCCURRENCE, AND LENGTH OF HOSPITALIZATION. THE ACUTE PAIN RELIEF AND THE BARROW NEUROLOGICAL INSTITUTE SCORE AT FOLLOW-UP WERE USED TO EVALUATE THE FUNCTIONAL OUTCOME. - RESULTS: THE CRANIOTOMY SIZE, THE SURGICAL DURATION, AND THE CSF LEAK INCIDENCE WERE SIGNIFICANTLY REDUCED IN GROUP A COMPARED WITH GROUP B (P [ 0.0009, P [ 0.0369, AND P [ 0.0406, RESPECTIVELY). THE INCIDENCE OF MASTOID AIR CELL OPENING, AND THE LENGTH OF HOSPITALIZATION WERE REDUCED IN GROUP A COMPARED WITH GROUP B, ALTHOUGH THESE DIFFERENCES WERE NOT STATISTICALLY SIGNIFICANT. WE OBTAINED AN ACUTE PAIN RELIEF IN ALL CASES, AND THE BARROW NEUROLOGICAL INSTITUTE SCORE AT FOLLOW-UP WAS SIGNIFICANTLY REDUCED (P <(><<)> 0.0001). -CONCLUSIONS: NEURONAVIGATION IS A USEFUL TOOL THAT SIGNIFICANTLY REDUCED CRANIOTOMY SIZE, SURGICAL DURATION, AND CSF LEAK INCIDENCE IN PATIENTS WITH TN SUBMITTED FOR MVD. WE ADVISE TO ROUTINELY IMPLEMENT NEURONAVIGATION IN THIS TYPE OF SURGERY. REPORTABLE EVENTS: 3 PATIENT HAD CEREBROSPINAL FLUID (CSF) LEAK SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873313 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other