NIM-Neuro® 8253401 (UDI 00613994499646)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994499646), received between Oct 23, 2018 and Nov 24, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Sense” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K083124); they may or may not involve this specific model.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2021Device Sensing Problem; Device Sensing Problem

  ADDITIONAL INFORMATION RECEIVED UPON COMMUNICATION WITH CUSTOMER THAT THE SYSTEM WAS NOT GIVING STIMULATION RESPONSE FOR ONE OF THE NERVES. DURING THE PROCEDURE, SYSTEM FAILED IN IDENTIFYING PROPER EMG RESPONSES. SIGNALED RESPONSES WHEN NO INTERACTIONS WERE HAPPENING - MAKING STRANGE SOUNDS AND BECAME UNRELIABLE. AN INTERVENTION DURING THE PROCEDURE OCCURRED WHERE THE SURGEON WAS ABLE TO SWITCH SYSTEM WITH 2ND SYSTEM ON SITE TO COMPLETE CASE. HE ALSO MENTIONED THAT AFTER THAT INCIDENT THE SAME SYSTEM WAS USED FOR SOME MORE CASES AND IT WAS WORKING FINE. THE PROCEDURE WAS DELAYED BY 45 MINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 12869297 ↗
• MalfunctionJun 5, 2019Failure to Sense; Failure to Sense

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE NERVE MONITORING SYSTEM WAS NOT REGISTERING ANY NERVES. THE DEVICE TESTED FINE BEFORE THE SURGERY. THERE WAS NO KNOWN PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8669942 ↗
• MalfunctionOct 23, 2018Failure to Sense; Failure to Sense

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT A NERVE MONITORING DEVICE WAS NON-RESPONSIVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7996316 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083124. One submission often covers many models, so check the product and lot details in each record.

• Z-2343-2012 · Sep 27, 2010 · Terminated
  Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box Label: REF 8253410 x1***NIM-Response 3.0 Patie
• Z-2344-2012 · Sep 27, 2010 · Terminated
  Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse). LABELING: Box Label: REF 8253210 x1***NIM-Response 3.0 Patie
• Z-2342-2012 · Sep 27, 2010 · Terminated
  Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1***NIM-Response 3.0 Patient