eNV® 9732781Recalls & reported problems
Medtronic Navigation, Inc. · TRACKER KIT, 9732781, HEAD · 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 00613994155573), received between Mar 11, 2017 and Mar 11, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device 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
- Use of Device Problem1
Patient problems
- Iatrogenic Source1
- Skin Discoloration1
- Skin Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 11, 2017Use of Device Problem; Use of Device Problem
A MEDTRONIC REPRESENTATIVE REPORTED THAT THE 9732781 HEAD TRACKER KIT WAS PUT ON IN AN OTORHINOLARYNGOLOGICAL SURGERY FOR THE PARANASAL SINUS. THE PROCEDURE LASTED FOR ABOUT 7 HOURS. THERE SEEMED NO ISSUE SOON AFTER THE SURGERY, HOWEVER, ON THE FOLLOWING DAY, BLISTERS AND REDNESS STARTED APPEARING ON THE PATIENT¿S FOREHEAD, WHERE THE DEVICE HAD BEEN PUT ON. THE PATIENT WAS TREATED BY A DERMATOLOGIST AFTERWARDS AND THE SYMPTOMS ARE IMPROVING. THE REP HAD INFORMED THE PHYSICIAN PRIOR TO THE PROCEDURE THAT SKIN IRRITATION MIGHT OCCUR AFTER A LONG SURGERY. THE REP SAW THE PHYSICIAN ONCE AGAIN ON (B)(6), AND CONFIRMED THAT THE PHYSICIAN WAS AWARE OF THE POSSIBLE SIDE EFFECT OF USING THE DEVICE FOR SUCH AN EXTENDED AMOUNT OF TIME.
Patient problems: Iatrogenic Source; Skin Discoloration; Skin Irritation
MAUDE report 6397823 ↗
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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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