MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION COMPACT ENT NAVIGATION SYSTEM; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9735602

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Inflammation (1932); Swelling (2091)

Event Date 11/14/2018

Event Type  Injury  

Manufacturer Narrative

Patient age is the mean value of patients in the cohort.Patient gender is the majority value of patients in the cohort.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.

Event Description

Citation: bruno galletti, francesco gazia, francesco freni, federico sireci, francesco galletti.Endoscopic sinus surgery with and without computer assisted navigation: a retrospective review.Summary: objective: in the last years endoscopic sinus surgery (ess) is improved with the introduction of computer assisted navigation (can).In this retrospective study we evaluated the usefulness of can in endoscopic sinus surgery and studied its advantages over conventional endoscopic sinus surgery.Methods: we retrospectively reviewed the records of 96 patients with chronic rhinosinusitis (crs).48 patients undergoing endoscopic sinus surgery with surgical navigation (a group) and other 48 without navigation (b group).Data about percentage of complications, olfactory function (visual analogue scale), sino-nasal outcomes test (snot-22), rhinosinusitis quality of life (rhinoqol), recurrence (ct lund¿mackay score), total nasal resistance (rhinomanometry) and duration of the intervention were collected and analyzed.Results: a group evidenced a decrease of recurrence rate (p = 0.009), a reduction of total nasal resistance (p = 0.007), of frontal recess stenosis (p = 0.04) and of nasal symptomatology (p = 0.008).Qol had a better improvement in group a.Rate of other complications and olfactory function did not show statistically significant differences between the two groups.The average calibration time was approximately 11 min in the a group.Total time of surgical procedure does not evidenced statistically significant difference between the two groups (p > 0.05) but if it is considered only the time of the surgical intervention, the difference of duration is significant reduced statistically (p <(><<)> 0.05) in can surgery.Conclusion: computer assisted navigation in ess can be useful for the most experienced surgeons, especially in the frontal recess surgery, decreasing the recurrence rate and reducing the total nasal resistance.Reported events: two patients in cohort a experienced crusty rhinitis.One patient in cohort a experienced a synechiae.

• Brand Name: FUSION COMPACT ENT NAVIGATION SYSTEM
• Type of Device: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9008221
• MDR Text Key: 160442773
• Report Number: 1723170-2019-04860
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K153247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9735602
• Device Catalogue Number: 9735602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR