StealthStation FlexENT
Received Jul 28, 2026 · Event occurred Mar 1, 2026
Report 1723170-2026-01065 · MDR key 50048506
Device
Generic name
Ear, Nose, And Throat Stereotaxic Instrument
Manufacturer
Medtronic Navigation, Inc.Model number
9736242Catalog number
9736242
Lot number
0012419349
Product problems
- Communication or Transmission Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that there was a malfunction with the DVD (Digital Video Disc) drive. When patient data was loaded from a DVD, data loss sometimes occurred. All data was missing. There was no patient involvement.
Additional Manufacturer Narrative
H3, H6: No products have been returned to Medtronic for analysis. Codes B17, C20, and D15 are applicable. 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.