BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 20481336 · Received October 18, 2024

    Report

    Report Number
    1723170-2024-03197
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    September 6, 2024
    Report Date
    October 18, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. A4) PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    BATTISTELLI, M., IZZO, A., D¿ERCOLE, M., D¿ALESSANDRIS, Q. G., DI DOMENICO, M., IOANNONI, E., GELORMINI, C., MARTINELLI, R., VALERI, F., GRILLI, F., MONTANO, N. OPTIMIZING SURGICAL TECHNIQUE IN MICROVASCULAR DECOMPRESSION FOR HEMIFACIAL SPASM ¿ RESULTS FROM A SURGICAL SERIES WITH CONTEMPORARY USE OF NEURONAVIGATION AND INTRAOPERATIVE NEUROMONITORING. SURGICAL NEUROLOGY INTERNATIONAL. 2024. 15 (319) DOI: 10.25259/SNI_268_2024 BACKGROUND: MICROVASCULAR DECOMPRESSION (MVD) THROUGH A RETROSIGMOID APPROACH IS CONSIDERED THETREATMENT OF CHOICE IN CASES OF HEMIFACIAL SPASM (HFS) DUE TO NEUROVASCULAR CONFLICT (NVC). DESPITE THE WIDESPREAD OF NEURONAVIGATION AND INTRAOPERATIVE NEUROMONITORING (IONM) TECHNIQUES IN NEUROSURGERY, THEIR CONTEMPORARY APPLICATION IN MVD FOR HFS HAS BEEN ONLY ANECDOTALLY REPORTED. METHODS: HERE, WE REPORT THE RESULTS OF MVD PERFORMED WITH A COMBINATION OF NEURONAVIGATION AND IONM, INCLUDING LATERAL SPREAD RESPONSE (LSR) IN 20 HFS PATIENTS. HFS CLINICAL OUTCOME AND DIFFERENT SURGICAL-RELATED FACTORS, SUCH AS CRANIOTOMY SIZE, SURGICAL DURATION, MASTOID AIR CELL (MAC) OPENING, POSTOPERATIVE CEREBRAL SPINAL FLUID (CSF) LEAKAGE, SINUS INJURY, AND OTHER COMPLICATIONS OCCURRENCE, AND THE LENGTH OF HOSPITALIZATION (LOS) WERE STUDIED. RESULTS: POSTOPERATIVELY, RESIDUAL SPASM PERSISTED ONLY IN TWO PATIENTS, BUT AT THE LATEST FOLLOW-UP (FU) (MEAN: 12.5 ± 8.98 MONTHS), ALL PATIENTS HAD RESOLUTION OF SYMPTOMS. THE MEAN SURGICAL DURATION WAS 103.35 ± 19.36 MIN, AND THE MEAN LOS WAS 2.21 ± 1.12 DAYS. CRANIOTOMY RESULTED IN 4.21 ± 1.21 CM2 IN SIZE. OPENING OF MAC HAPPENED IN TWO CASES, WHEREAS NO CASES OF CSF LEAK WERE REPORTED AS WELL AS NO OTHER COMPLICATIONS POSTOPERATIVELY AND DURING FU. CONCLUSION: MVD FOR HFS IS AN ELECTIVE PROCEDURE, AND FOR THIS REASON, SURGERY SHOULD INTEGRATE ALL TECHNOLOGIES TO ENSURE SAFETY AND EFFICACY. THE DISAPPEARANCE OF LSR IS A CRUCIAL FACTOR FOR IDENTIFYING THE VESSEL RESPONSIBLE FOR NVC AND FOR ACHIEVING LONG-TERM RESOLUTION OF HFS SYMPTOMS. SIMULTANEOUSLY, THE BENEFITS OF USING NEURONAVIGATION, INCLUDING THE ABILITY TO CUSTOMIZE THE CRANIOTOMY, CONTRIBUTE TO REDUCE THE POSSIBILITY OF COMPLICATIONS. REPORTED EVENTS: OPENING OF MAC HAPPENED IN TWO CASES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2271394 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male