Neurosign Disposable Concentric Probe 3600-00-TERecalls & reported problems
The Magstim Company Limited · 100mm x 1mm electrodes; 1.9m twisted wire with DIN42802 connectors. · 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 05060229530660), received between Jul 3, 2018 and Jul 3, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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
- Device Operates Differently Than Expected1
Patient problems
- Facial Nerve Paralysis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2018Device Operates Differently Than Expected
PATIENT (B)(6) (F, (B)(6)), UNDERWENT A STAPEDECTOMY SURGERY INDICATED FOR OTOSCLEROSIS ON THE (B)(6) 2018. THE PATIENT HAD AN ABERRANT FACIAL NERVE. DURING THE SURGERY A NEUROSIGN 100 AND A NEUROSIGN CONCENTRIC PROBE WERE USED FOR NERVE MONITORING. AS REPORTED BY THE CUSTOMER, THE DEVICE DID NOT IDENTIFY DIRECT STIMULATION OR MANIPULATION OF THE NERVE. THE PATIENT WAS REVIEWED IN THE RECOVERY UNIT (PACU) AFTER THE SURGERY, WHERE THE SURGEON NOTICED FACIAL ASYMMETRY, OR ALSO REPORTED AS PARTIAL FACIAL PALSY, WHICH COULD POTENTIALLY BE A PERMANENT INJURY.
Patient problems: Facial Nerve Paralysis
MAUDE report 7657793 ↗
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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