NeuroNavRecalls & reported problems
Alpha Omega Engineering CO. Ltd. · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290014954052), received between Nov 13, 2019 and Jun 20, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Disconnection” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Disconnection1
- Self-Activation or Keying1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2023Disconnection; Disconnection
THE NEURONAV HDD LAPTOP FAILED, SO THE SYSTEM LAPTOP FAILED TO BOOT, AN ALTERNATIVE NEUROSMART SYSTEM FROM ANOTHER HOSPITAL WAS BORROWED, SO THE HOSPITAL PROCEEDED WITH THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17161253 ↗MalfunctionNov 13, 2019Self-Activation or Keying; Unintended Movement
DURING A DBS IMPLANTATION NEUROSURGERY, THE NEUROSURGEON FINISHED THE MICROELECTRODE RECODING PHASE AND PLACED THE IMPLANTED LEAD IN PLACE. THE NEUROSURGEON NOTICED THAT THE HEADSTAGE DRIVE WAS MOVING ON ITS OWN AND HAD MOVED IN 2 MM. THE NEUROSURGEON DISCONNECTED THE HEADSTAGE CABLE AND DECIDED TO CONTINUE THE NEUROSURGERY BY USING THE MANUAL ELECTRODE MOVING OPTION AND THE DBS ELECTRODE WAS SUCCESSFULLY IMPLANTED. NO ADVERSE EVENT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9315226 ↗
Other Electrode, Depth devices
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- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.