N/A 9732500Recalls & reported problems
Medtronic Navigation, Inc. · ADHESIVE PAD 9732500 HEAD TRACKER 25PK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994155559), received between Oct 31, 2018 and Oct 31, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Biocompatibility” (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
- Biocompatibility1
Patient problems
- Skin Irritation1
- Tissue Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 31, 2018Biocompatibility; Biocompatibility
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT HOURS AFTER THE SURGERY, THE PATIENT PRESENTED AN 'AFFECTATION' IN THE SKIN OF THEIR FOREHEAD IN THE PRESSURE AREA OF THE ADHESIVE PAD. NOTHING WAS OBSERVED DURING THE PROCEDURE; JUST A PRESSURE MARK ASSOCIATED WITH NORMAL USE. THE 'AFFECTATION' ON THE PATIENT'S FOREHEAD WAS DIAGNOSED AS EPIDERMOLYSIS DUE TO CONTACT. THE PATIENT WAS FINISHING THEIR SURGERY RECOVERY IN THE INTENSIVE CARE UNIT (ICU) AND WAS BEING TREATED BY A DERMATOLOGIST. THE DOCTOR REPORTED THAT THE SKIN PROBLEM SEEMED LIKE A SECOND-DEGREE BURN, WHICH WAS CRUSTING, POSSIBLY CAUSED BY A REACTION TO THE CHEMICAL AGENTS.
Patient problems: Skin Irritation; Tissue Damage
MAUDE report 8026081 ↗
Other Neurological stereotaxic Instrument devices
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument4 deaths4,668 reports
- Stealthstation® S7™ 9733856Medtronic Navigation, Inc. · Neurological stereotaxic Instrument6 deaths3,908 reports
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death1,896 reports
- StealthStation S8 9735669Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1,831 reports
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument2 deaths1,542 reports
- Fusion™ ENT Image Guidance System 9733560XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument1,316 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument8 deaths984 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death695 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page