PULSE 50120104Recalls & reported problems
Nuvasive, Inc. · MIOM Electrode Kit, Needle · Class 2
- 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 00887517939869), received between Jan 11, 2023 and Jan 11, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 11, 2023Fracture; Fracture
FOLLOWING A CASE IN WHICH INTEROPERATIVE NEUROMONITORING WAS USED, A NEEDLE ELECTRODE BROKE OFF INSIDE THE PATIENT'S SKIN DURING NEEDLE REMOVAL. THE SURGEON SURGICALLY EXCISED THE BROKEN NEEDLE TO REMOVE IT FORM THE PATIENT, WHICH ALSO DELAYED WAKEUP BY APPROXIMATELY 1 HOUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16137611 ↗
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- Natus 515-016200Natus Neurology Incorporated · Electromyograph, Diagnostic1 report
- NA 8225490Medtronic Xomed, Inc. · Electromyograph, diagnostic1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.