NIM-Response® 8253200RFRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994858399), received between Aug 28, 2017 and May 24, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Sensing Intermittently” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 24, 2022False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PI GIVES FALSE READINGS AND SWITCHES TO DIFFERENT MODES. THERE WAS A PATIENT IMPACT - NERVE WAS INJURED DURING PROCEDURE.

  Patient problems: Nerve Damage

  MAUDE report 14488235 ↗
• MalfunctionOct 11, 2017False Negative Result; False Negative Result

  THE FACILITY REPORTED THAT THERE WAS NO STIMULATION RESPONSE FROM THE NIM SYSTEM. BIOMEDICAL ENGINEER AT THE FACILITY COULD NOT DUPLICATE THE ISSUE OF NO STIMULATION RESPONSE THAT WAS FOUND DURING SURGERY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6943149 ↗
• MalfunctionOct 9, 2017Sensing Intermittently; Sensing Intermittently

  THE FACILITY REPORTED THAT IN TWO PROCEDURES, INTRA-OPERATIVE THE NIM SYSTEM WAS GIVING INTERMITTENT READINGS WHEN IT WAS "FIRED." THE FIRST PROCEDURE OCCURRED ON (B)(6) 2017 AND THE SECOND PROCEDURE OCCURRED ON (B)(6) 2017. BOTH PROCEDURES WERE COMPLETED. THERE WAS NO REPORT OF PATIENT IMPACT ON BOTH PROCEDURES. REGULATORY REPORT # 1045254-2017-00353 WAS FILED FOR PROCEDURE 1 OF 2 THAT OCCURRED ON (B)(6) 2017 ((B)(4)). THIS REGULATORY REPORT IS BEING FILED FOR PROCEDURE 2 OF 2 THAT OCCURRED ON (B)(6) 2017 ((B)(4)).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6931766 ↗
• MalfunctionOct 9, 2017Sensing Intermittently; Sensing Intermittently

  THE FACILITY REPORTED THAT IN TWO PROCEDURES, INTRA-OPERATIVE THE NIM SYSTEM WAS GIVING INTERMITTENT READINGS WHEN IT WAS "FIRED." THE FIRST PROCEDURE OCCURRED ON (B)(6) 2017 AND THE SECOND PROCEDURE OCCURRED ON (B)(6) 2017. BOTH PROCEDURES WERE COMPLETED. THERE WAS NO REPORT OF PATIENT IMPACT ON BOTH PROCEDURES. THIS REGULATORY REPORT IS BEING FILED FOR PROCEDURE 1 OF 2 THAT OCCURRED ON (B)(6) 2017 (MEDTRONIC INTERNAL REFERENCE NUMBER (B)(4)). ANOTHER REGULATORY REPORT WILL BE FILED FOR PROCEDURE 2 OF 2 THAT OCCURRED ON (B)(6) 2017 (MEDTRONIC INTERNAL REFERENCE NUMBER (B)(4)).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6931765 ↗
• MalfunctionSep 22, 2017Sensing Intermittently; Sensing Intermittently

  THE FACILITY REPORTED THAT INTRA-OPERATIVE THE NIM SYSTEM WAS GIVING AN INTERMITTENT RESPONSE. THE SYSTEM WOULD RESPOND SOMETIMES AND SOMETIMES IT WOULD NOT. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WERE THREE OCCURRENCES OF THIS EVENT WITH THIS SYSTEM. THIS REGULATORY REPORT IS BEING FILED FOR EVENT 1 OF 3 ((B)(4)). ANOTHER REGULATORY REPORT WILL BE FILED FOR EVENT 2 OF 3 ((B)(4)). EVENT 3 OF 3 OCCURRED ON (B)(6) 2017 AND WAS FILED UNDER THE REGULATORY REPORT # 1045254-2017-00297 ((B)(4)). EVENT DATES OR SPECIFIC INFORMATION FOR EVENTS 1 OF 3 AND 2 OF 3 ARE UNKNOWN. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FOR THESE PREVIOUS EVENTS HAVE BEEN UNSUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6888158 ↗
• MalfunctionSep 22, 2017Sensing Intermittently; Sensing Intermittently

  THE FACILITY REPORTED THAT INTRA-OPERATIVE THE NIM SYSTEM WAS GIVING AN INTERMITTENT RESPONSE. THE SYSTEM WOULD RESPOND SOMETIMES AND SOMETIMES IT WOULD NOT. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WERE THREE OCCURRENCES OF THIS EVENT WITH THIS SYSTEM. EVENT 1 OF 3 WAS FILED UNDER REGULATORY REPORT # 1045254-2017-00330 ((B)(4)). THIS REGULATORY REPORT IS BEING FILED FOR EVENT 2 OF 3 ((B)(4)). EVENT 3 OF 3 OCCURRED ON (B)(6) 2017 AND WAS FILED UNDER THE REGULATORY REPORT # 1045254-2017-00297 ((B)(4)). EVENT DATES OR SPECIFIC INFORMATION FOR EVENTS 1 OF 3 AND 2 OF 3 ARE UNKNOWN. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FOR THESE PREVIOUS EVENTS HAVE BEEN UNSUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6888149 ↗
• MalfunctionAug 28, 2017Sensing Intermittently; Sensing Intermittently

  THE FACILITY REPORTED THAT INTRA-OPERATIVE THE NIM SYSTEM WAS GIVING AN INTERMITTENT RESPONSE. THE SYSTEM WOULD RESPOND SOMETIMES AND SOMETIMES IT WOULD NOT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6826183 ↗

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-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
• 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-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