NIM ContactRecalls & reported problems across all models

We found 6 models of NIM Contact by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 14 adverse event reports in the FDA's MAUDE database, received between Apr 13, 2018 and Apr 17, 2024 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

NIM Contact recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 29, 2022Open, Classified

   The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.

   Z-1519-2022 · Root cause: Under Investigation by firm · names 6 of these models · Recall details · FDA record ↗

Most reported NIM Contact problems

NIM Contact models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• NIM CONTACT® 8229507

  STIMULATOR, NERVE
  1 recall6 reports
• NIM CONTACT® 8229506

  STIMULATOR, NERVE
  1 recall4 reports
• NIM CONTACT® 8229508

  STIMULATOR, NERVE
  1 recall2 reports
• NIM Contact 8229507

  STIMULATOR, NERVE
  1 recall1 report
• NIM Contact 8229508

  STIMULATOR, NERVE
  1 recall1 report
• NIM Contact 8229506

  STIMULATOR, NERVE
  1 recall0 reports

Recent NIM Contact adverse event reports

The 14 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION STATES THAT STIM RETURN SHOWED THE AMOUNT BEING APPLIED. CURRENT DELIVERY TONE WAS HEARD AND NEVER GOT A POSITIVE RESPONSE. THERE WAS NO VISUAL AND/OR AUDIBLE INDICATOR THAT ALERTED THE USER OF THE ISSUE. SURGEON BELIEVES ISSUE WAS WITH TUBE. CONFIRMED PATIENT WAS NOT PARALYZED. TUBE WAS REPOSITIONED AND WE WERE STILL UNABLE TO GET A RESPONSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122906 ↗
• MalfunctionMar 18, 2024Break; Break

  IT WAS REPORTED THAT DURING THE THYROIDECTOMY PROCEDURE NIM TUBE STYLET WAS PUT INTO NIM TUBE TO FACILITATE THE CMAC INTUBATION. UPON CURVATURE, WE DIDN'T NOTICE THE NIM WIRE DETACH. THE WIRE WAS CAUGHT IN THE HYPOPHARYNX AND PREVENTED THE NIM TUBE FROM GOING INTO THE TRACHEA. THE NIM TUBE WAS REMOVED AND A REGULAR 7.0 ET TUBE WAS USED INSTEAD TO INTUBATE THE PATIENT. UPON REMOVAL OF THE NIM TUBE, FRESH BLOOD WAS NOTICED AT THE INSERTION TIP OF THE NIM TUBE. THE WIRE WAS CAUGHT IN THE HYPOPHARYNX AND CAUSED BLEEDING. THE PATIENT IS OK FOR THE TIME BEING ACCORDING TO THE CHARGE NURSE. THE EVENT WAS RESULTED IN A PROCEDURE DELAY. THE PATIENT WAS ALIVE - WITH INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s); Unintended Extubation

  MAUDE report 18919359 ↗
• MalfunctionMar 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT INTRA OP DEVICE HAS UNEXPLAINED ACTIVITY ON CHANNEL 2. THERE WAS POSSIBLE SPONTANEOUS EMG AS IT HAD BIPHASIC WAVELENGTHS. TROUBLESHOOTING WAS DONE BY USER THAT USER LET 1-2ML OF AIR OUT OF THE CUFF AND SWAPPED RED AND BLUE ELECTRODES WITH EACH OTHER TO ELIMINATE A PI BOX ISSUE. THE ACTIVITY FOLLOWED THE CHANNEL WHEN SWAPPED RED AND BLUE ON PI BOX. THE ACTIVITY WENT AWAY ABOUT 5 MINUTES AFTER SWITCHING THE RED AND BLUE ELECTRODES WITH EACH OTHER ON PI BOX. USER WAS ABLE TO STIMULATE AND USE THE NIM VITAL FOR MONITORING THROUGHOUT THE CASE. AND ELECTRODE CHECK WAS PERFORMED. THERE WAS NO DELAY IN CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18905376 ↗
• InjuryAug 18, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT WHILE NIM ENDOTRACHEAL TUBE PLACED WITH VIDEOSCOPE, VENTILATED WELL FOR SEVERAL MINUTES THEN HIGH PEAK PRESSURES/NO VENTILATION, ASSESSMENT AND TREATMENT OF PATIENT, VENTILATION ONLY IMPROVED WHEN TUBE REPLACED WITH STANDARD ENDOTRACHEAL TUBE. SEE ATTACHED USER FACILITY MEDWATCH MW5119519.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 17574530 ↗
• InjuryJul 14, 2023Increase in Pressure

  USING MEDTRONIC NIMS ENDOTRACHEAL TUBE PLACED WITH VIDEOSCOPE, VENTILATED WELL FOR SEVERAL MINUTES THEN HIGH PEAK PRESSURES/NO VENTILATION, ASSESSMENT AND TREATMENT OF PATIENT, VENTILATION ONLY IMPROVED WHEN TUBE REPLACED WITH STANDARD ENDOTRACHEAL TUBE.

  Patient problems: Insufficient Information

  MAUDE report 17337130 ↗
• MalfunctionMar 13, 2023Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE, TUBE DID NOT WORK AS INTENDED. APPLIED BEFORE START OF CASE (AS USUAL), WHEN PROBE PLACED ON NERVE NIM TUBE DID NOT REGISTER. NO INTERVENTION PERFORMED. THE REPORTED EVENT RESULT IN A PROCEDURE DELAY 5-10 MINUTES DURING SET-UP. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT(S). NO PATIENT INJURY REPORTED. THERE WAS NO ANY VISUAL AND/OR AUDIBLE INDICATORS THAT ALERTED THE USER OF THE ISSUE. THE ISSUE DID NOT RESOLVED BY REPOSITIONING OR TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16528858 ↗
• MalfunctionJan 25, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PATIENT WAS INTUBATED WITH ENDOTRACHEAL TUBE,WHEN THE TUBE WAS ATTACHED TO THE NERVE INTEGRITY MONITOR MACHINE, IT DID NOT WORK. THE ENDOTRACHEAL TUBE WAS FUNCTIONING PROPERLY, BUT THE NIM CAPABILITY DID NOT FUNCTION. THE TUBE WAS REPLACED WITH ANOTHER IDENTICAL DEVICE, AND THE SECOND ONE WORKED PROPERLY WITH THE NERVE INTEGRITY MONITOR MACHINE. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16242643 ↗
• InjuryDec 14, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PROCEDURE ONCE THE PATIENT WAS INTUBATED, THE ANESTHESIOLOGIST NOTICED THAT THE TUBE WAS LEAKING, CHECKED AND VERIFIED THAT IT WAS BROKEN. NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THERE WAS NO INJURY TO PATIENT. ON FOLLOW-UP IT WAS REPORTED THAT THE SLEEVE AND TUBING CHECKED PRIOR TO USE TO ENSURE PROPER OPERATION AND IT WORKED. THE ANESTHESIOLOGIST NOTICED THE ISSUE AFTER INTUBATION AND AIRWAY WAS ESTABLISHED. THE PATIENT WAS NO RE-POSITIONED. CUFF PRESSURE NOT QUANTITATIVELY MONITORED. THERE WAS ONLY USUAL DIFFICULTY OF THE CONTACT TUBE. AIR WAS USED TO INFLATE THE CUFF. BITE BLOCK NOT USED TO SECURE THE TUBE. EXTUBATE THE PATIENT AND USED A NEW TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 15983912 ↗
• MalfunctionSep 9, 2022Failure to Sense; Failure to Sense

  ON FOLLOW-UP IT WAS REPORTED THAT STIMULUS ADJUSTED FIRST TO 0.8 AND THEN TO 1.0. THRESHOLD SET TO 100. NO BASELINE WAS PERFORMED. THE PATIENT'S NERVE INTEGRITY CHECKED BEFORE CLOSING THE SITE WITH COMPETITOR'S STIMULATOR. THERE WAS NO VISUAL AND/OR AUDIBLE INDICATORS TO ALERT THE USER TO THE PROBLEM AND THERE WAS NO ERROR CODE DISPLAYED. NO WAVEFORM DISPLAYED. A SHORT-ACTING RELAXANT WAS USED AND AFTER 30 MINUTES THE ANESTHESIOLOGIST PERFORMED THE TESTS WITH THE EQUIPMENT INTENDED FOR THIS PURPOSE AND IT WAS FOUND THAT THE MUSCLE RELAXANT WAS NO LONGER PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15394397 ↗
• MalfunctionAug 22, 2022Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT COULD NOT MAKE THE DEVICE TO WORK. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15268275 ↗
• MalfunctionAug 22, 2022Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT COULD NOT MAKE THE DEVICE TO WORK. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15268248 ↗
• MalfunctionJul 19, 2022Use of Device Problem; Use of Device Problem

  THE HCP REPORTED THAT TUBE WAS INSERTED INTO THE TRACHEA PAST THE VOCAL CORDS AND WHEN THE NIM TUBE WAS STIMULATED IT DID NOT WORK. THERE WERE NO ADVERSE PATIENT ISSUES. THE ANESTHESIA PERSONAL WERE ABLE TO REINTUBATED USING A NIM 7.0 TUBE INSTEAD. THE SURGERY COMPLETED WITH ANESTHESIA REINTUBATED USING A NIM 7.0 TUBE INSTEAD.

  Patient problems: Unintended Extubation

  MAUDE report 15054515 ↗
• MalfunctionFeb 16, 2022Gas/Air Leak; Gas/Air Leak

  HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTUBATION PROCESS CUFF WAS NOT HOLDING AIR, HAD TO EXTUBATE THE TUBE AND BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF 10 MIN, NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13540055 ↗
• MalfunctionApr 13, 2018Inflation Problem; Inflation Problem

  THE CUSTOMER REPORTED THAT INTEROPERATIVE, THERE WAS AN INFLATION/DEFLATION ISSUE WITH THE ENDODTRACHEAL TUBE CUFF. PATIENT REINTUBATION WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 7430332 ↗

Other Medtronic Xomed, Inc. products

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