Neurosign V4 1699-00-TERecalls & reported problems
Technomed Engineering B.V. · Disposable Twisted Pair Electrodes; 1m cable with TP DIN 42802 connector · Class 2
All models of Neurosign V4 (3)
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 08718375865224), received between Jun 30, 2023 and Jun 30, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.
InjuryJun 30, 2023Fracture; Fracture
THE METAL PORTION OF THE NEEDLE ELECTRODE BROKE OFF IN THE PATIENT AND HAD TO BE CUT OUT. A SCOLIOSIS CORRECTION WAS BEING PERFORMED. ALL NEEDLE ELECTRODES, GROUNDS, CORKSCREWS AND ADHESIVE ELECTRODE PLACED AS USUAL AND PROCEDURE COMMENCED. NOTHING UNUSUAL TO REPORT DURING THE PROCEDURE. AFTER THE PROCEDURE, IT WAS NOTICED ONE NEEDLE WAS MISSING, AN X-RAY WAS TAKEN AND THE NEEDLE FOUND IN THE PATIENT, AT THE KNEE. THE NEEDLE WAS CUT OUT TO BE REMOVED. THE PATIENT IS DOING FINE. THERE WAS NO CHANGE IN SURGICAL OUTCOME AND NO IMPACT ON PATIENT HEALTH. THE NEEDLE COULD EASILY BE FOUND AND THE CUT MADE WAS DESCRIBED AS VERY SMALL. A SMALL PLASTER AND FEW STITCHES WERE USED TO CLOSE THE WOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17235379 ↗
Other Electrode, Needle devices
- Technomed Europe TE/S50715-003Technomed Engineering B.V. · Electrode, Needle1 recall0 reports
- Technomed Europe TE/S50715-002Technomed Engineering B.V. · Electrode, Needle1 recall0 reports
- Technomed Europe TE/S50725-002Technomed Engineering B.V. · Electrode, Needle1 recall0 reports
- Technomed Europe TE/S50725-002-CTechnomed Engineering B.V. · Electrode, Needle1 recall0 reports
- Neurosign V4 5888-00Technomed Engineering B.V. · Electrode, Needle1 recall0 reports
- Rhythmlink® RLSND121-2.5Rhythmlink International, LLC · Electrode, Needle5 reports
- NA 8227411Medtronic Xomed, Inc. · ELECTRODE, NEEDLE4 reports
- Rhythmlink® RLSP503Rhythmlink International, LLC · Electrode, Needle3 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.
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