N/A 9735300Recalls & reported problems
Medtronic Navigation, Inc. · PATIENT TRACKER 9735300 SKULL MOUNT PKGD · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169490017), received between Aug 30, 2018 and Aug 30, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Communication or Transmission Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 30, 2018Communication or Transmission Problem; Communication or Transmission Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT INTRA/PERI-OPERATIVELY DURING THE NAVIGATE TASK OF AN ELECTRODE AND LEAD PLACEMENT PROCEDURE, THE DYNAMIC REFERENCE FRAME (DRF) WOULD FLICKER IN AND OUT OF VIEW. THE SITE STATED THIS IS THE ONLY INSTRUMENT THAT SEEMS TO BE AFFECTED. DRF FLICKERED FOR ENTIRE CASE. AFTER THE CASE, THE SITE TESTED THE DRF HOLDING IT IN THE AIR OFF THE BED WITH THE EMITTER HELD UP TO IT, AND THE DRF STILL FLICKERED. THE SITE ATTEMPTED MULTIPLE DRFS, THE SAME RESULT OCCURRED. ALL OTHER INSTRUMENTS TRACKED COMPLETELY FINE. THE SITE ALSO STATED THEY SUSPECTS IT WAS THE BED, PER THE PREVIOUS CASE WHERE THIS HAPPENED ((B)(4)). THERE WAS A DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7832330 ↗
Other Neurological stereotaxic Instrument devices
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- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death1,896 reports
- StealthStation S8 9735669Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1,831 reports
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- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument8 deaths984 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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