NIM FLEXRecalls & reported problems across all models

We found 5 models of NIM FLEX by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between May 4, 2017 and Sep 28, 2020 — classified as 15 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Partial Blockage” (7 reports).

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

Most reported NIM FLEX problems

NIM FLEX models

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

• NIM FLEX™ 8229970

  STIMULATOR, NERVE
  11 reports
• NIM FLEX™ 8229975

  STIMULATOR, NERVE
  8 reports
• NIM FLEX™ 8229965

  STIMULATOR, NERVE
  2 reports
• NIM FLEX™ 8229980

  STIMULATOR, NERVE
  2 reports
• NIM FLEX™ 8229985

  STIMULATOR, NERVE
  1 report

Recent NIM FLEX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 28, 2020Blocked Connection; Blocked Connection

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT DURING SURGERY, ANAESTHETIST WAS UNABLE TO VENTILATE PATIENT ADEQUATELY AND WHILE TRYING TO PASS A SUCTION CATHETER THROUGH THE TUBE IT WAS FOUND TO BE BLOCKED AS THE CATHETER WOULDN¿T GO IN. WE CHANGED TO ANOTHER TUBE AND RESUMED SURGERY. WHEN EXAMINING THE TUBE, THE INTERNAL LUMEN WAS FOUND BLOCKED WITH BULGING OF THE ARMOUR MATERIAL INTERNALLY ESPECIALLY WHEN BENT.

  Patient problems: Extubate

  MAUDE report 10592200 ↗
• MalfunctionNov 26, 2019Use of Device Problem; Use of Device Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE NERVE MONITORING FOR THE TUBE WORKED FOR THE FIRST PART OF THE OPERATION AND THEN STOPPED WORKING DURING A RECURRENT LARYNGEAL NERVE MONITORING CASE. ALL CONNECTIONS AND TUBE PLACEMENT WERE CHECKED - STILL NOT WORKING. ANAESTHETIST CHANGED TO A NEW TUBE WHICH WORKED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9376358 ↗
• InjuryOct 15, 2019Obstruction of Flow; Obstruction of Flow

  A HEALTHCARE PROVIDER (HCP) REPORTED VIA A DISTRIBUTOR THAT THE ANESTHESIOLOGIST INTUBATED THE PATIENT WITH STIMULATION CANNULA WHICH WAS DELIVERED AT THE FACILITY A DAY BEFORE. AFTER APPROXIMATELY 30 MINUTES, OVERALL ANESTHESIA IN THE PATIENT DECREASED RESPIRATORY VOLUME AND INCREASED AIRWAY PRESSURE. DURING THE INSPECTION OF THE TUBE, IT WAS FOUND THAT THE INNER LUMEN OF THE CANNULA WAS OBSTRUCTED AT A DISTANCE OF 26-28 CM. THE PATIENT WAS THEN RE-INTUBATED WITH A NEW TUBE. AFTER PERFORMING THE VISUAL INSPECTION, IT WAS FOUND THAT WHEN INFLATING THE CANNULA CUFF, THE INNER LUMEN OF THE CANNULA SEPARATES THE INNER LINING OF THE CANNULA, CREATING A BULGE PREVENTING VENTILATION OF THE PATIENT AS IT COMPLETELY OBSTRUCTS THE TUBE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: Airway Obstruction; Extubate

  MAUDE report 9191046 ↗
• MalfunctionJun 19, 2019Material Separation; Material Separation

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT VIA A DISTRIBUTOR THAT DURING A THYROIDECTOMY PROCEDURE, THE TUBE WAS POSITIONED AT THE PATIENT AND SUDDENLY THE ELECTRODE PART DETACHED AND FELL. THEY CONTINUED USING THE TUBE WITHOUT THE ELECTRODE AND USING CHEANG¿S METHOD TO DO MONITORING. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8714466 ↗
• InjuryMay 6, 2019Partial Blockage; Partial Blockage

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THERE WAS INCREASING DIFFICULTY VENTILATING THE PATIENT DURING THYROID SURGERY. BRONCHOSCOPY REVEALED INNER HERNIATION OF ENDOTRACHEAL TUBE INTO LUMEN OF THE TUBE OBSTRUCTING VENTILATION. THE DEVICE WAS CHANGED AND PROBLEM WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT INJURY.

  Patient problems: Airway Obstruction

  MAUDE report 8583889 ↗
• MalfunctionJan 11, 2019False Positive Result; False Positive Result

  ADDITIONAL INFORMATION STATED THAT THE ANARCHIC SIGNAL MEANT ARTIFACT; THE WAVES ON THE SCREEN. THE ANESTHETIC DRUG USED ON THE PATIENT WAS PROPOFOL WITH SEVOFLURANE GAS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8241256 ↗
• MalfunctionNov 28, 2018Unable to Obtain Readings; Unable to Obtain Readings

  ADDITIONAL INFORMATION RECEIVED STATED THAT DURING THE CHECK UP FOR TUBE POSITION AFTER THE AIRWAY WAS ESTABLISHED, IN CONTROL OF ELECTRODE PART, ALL CROSSES WERE RED WHEREAS THE TUBE WAS CORRECTLY POSITIONED AND CABLES WIRED; THE PATIENT INTERFACE AND RETURN ELECTRODES ON PATIENT BREAST, TOO. A SECOND TUBE WAS USED BUT, THE ISSUE WAS NOT RESOLVED. THEN, TOOK A THIRD TUBE WITH A DIFFERENT LOT NUMBER AND FINALLY, ALL THE CROSSES BECAME GREEN. THEY LOST TIME BUT THERE WAS NO PATIENT IMPACT AND THE CASE WAS COMPLETED. THE ISSUE REPEATED ALL WEEK WHEN TUBE IN THE SAME LOT NUMBER WAS USED; EVEN WITH THE SAME MAINFRAME AND DIFFERENT MEDICAL STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8112005 ↗
• InjuryNov 20, 2018Peeled/Delaminated; Peeled/Delaminated

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TUBE WAS ROUTINELY PLACED BY THE ANESTHESIOLOGIST PRIOR TO THE THYROID PROCEDURE. THE INTUBATION WAS USED NORMALLY WITHOUT ANY PROBLEMS. HOWEVER, SHORTLY BEFORE THE PATIENT WAS THEN PLACED IN THE OPERATING ROOM, THERE WAS AN INCREASE OF THE VENTILATION PRESSURE. THE VENTILATION PRESSURE WAS NOTICED AFTER THE AIRWAY WAS ESTABLISHED. SO, THE ANESTHESIOLOGIST DECIDED TO EXTUBATE THE TUBE AND INTUBATE THE PATIENT AGAIN WITH ANOTHER NEW TUBE. THE DELAY TIME WAS ONLY WHEN THE EXTUBATION AND THE NEW INTUBATION OF THE TUBE. THEN ALL WAS FINE AND THE THYROID PROCEDURE WAS PERFORMED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT IMPACT AFTER THE PROCEDURE AS STATUS OF PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: Extubate; Occlusion

  MAUDE report 8091032 ↗
• InjuryNov 15, 2018Partial Blockage; Use of Device Problem; Fitting Problem; Partial Blockage; Use of Device Problem; Fitting Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TUBE DID NOT WORK PROPERLY DURING A PROCEDURE. THE HCP MENTIONED THAT IT SEEMED THAT THE BALLOON WAS LOOSE. AFTER 20 MINUTES, THE TUBE STARTED TO OBTURATE AND THE INNER LUMEN WAS CLOSED UNDER PRESSURE OF THE BALLOON. AFTER 30 MINUTES, THE TUBE WAS CHANGED SINCE THE PATIENT WAS NOT VENTILATED.

  Patient problems: Airway Obstruction; Extubate

  MAUDE report 8073625 ↗
• InjuryNov 15, 2018Partial Blockage; Use of Device Problem; Fitting Problem; Partial Blockage; Use of Device Problem; Fitting Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TUBE DID NOT WORK PROPERLY DURING A PROCEDURE. THE HCP MENTIONED THAT IT SEEMED THAT THE BALLOON WAS LOOSE. AFTER 20 MINUTES, THE TUBE STARTED TO OBTURATE AND THE INNER LUMEN WAS CLOSED UNDER PRESSURE OF THE BALLOON. AFTER 30 MINUTES, THE TUBE WAS CHANGED SINCE THE PATIENT WAS NOT VENTILATED.

  Patient problems: Airway Obstruction; Extubate

  MAUDE report 8073555 ↗
• InjuryNov 15, 2018Partial Blockage; Use of Device Problem; Fitting Problem; Partial Blockage; Use of Device Problem; Fitting Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE TUBE DID NOT WORK PROPERLY DURING A PROCEDURE. THE HCP MENTIONED THAT IT SEEMED THAT THE BALLOON WAS LOOSE. AFTER 20 MINUTES, THE TUBE STARTED TO OBTURATE AND THE INNER LUMEN WAS CLOSED UNDER PRESSURE OF THE BALLOON. AFTER 30 MINUTES, THE TUBE WAS CHANGED SINCE THE PATIENT WAS NOT VENTILATED.

  Patient problems: Airway Obstruction; Extubate

  MAUDE report 8073528 ↗
• InjuryNov 7, 2018Partial Blockage; Partial Blockage

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT DURING THE INCISION, THERE WAS SUDDENLY RESPIRATORY HYPER PRESSURE AND IMPOSSIBILITY OF VENTILATION. STRONG DESATURATION WAS APPLIED AND THE SURGERY WAS STOPPED IMMEDIATELY. THERE WAS EXTUBATION ON (B)(6) AND REVENTILATION WITH MASK, RE-SATURATION AND RE-INTUBATION ON EISCMAN. IN CONCLUSION AND AFTER CHECKING, THE TUBE HAD AN INTRALUMINAL HERNIA WHEN INFLATING BALLOON. THIS PREVENTED ANY VENTILATION. PATIENT WAS ALIVE-NO INJURY. THERE WAS NO PATIENT IMPACT.

  Patient problems: Extubate; Low Oxygen Saturation; Respiratory Distress

  MAUDE report 8048086 ↗
• InjuryOct 11, 2018Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE ANESTHETIST REFERRED THAT THE PATIENT DID NOT BREATHE CORRECTLY AFTER INTUBATION DURING THE PROCEDURE. THE TUBE HAD A MALFUNCTION DURING A THYROID PROCEDURE. THEY HAVE USED THE TUBE CORRECTLY AND HAVE CHECKED THE DIFFERENT PARAMETERS OF THE ANESTHESIA WORKSTATION AND DECIDED TO CHANGED FOR ANOTHER TUBE. THE CUFF WAS ABLE TO BE INFLATED AND THE AIRWAY WAS ESTABLISHED. THE NURSE HAD CHECKED THE CUFF BEFORE INTUBATION WITH THE FLEX TUBE. THIS WAS THE INITIAL USE FOR NERVE INTRAOPERATIVE MONITORING. THEY DECIDED TO CHANGE THE TUBE. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: Dyspnea; Extubate

  MAUDE report 7955912 ↗
• InjuryOct 4, 2018Failure to Read Input Signal; Failure to Read Input Signal

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE ENDOTRACHEAL TUBE WAS USED FOR THE FIRST TIME.

  Patient problems: Extubate

  MAUDE report 7935957 ↗
• InjuryAug 27, 2018Unable to Obtain Readings; Use of Device Problem; Unable to Obtain Readings; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE RED CIRCUIT OF THE TUBE WAS NOT WORKING DURING A THYROIDECTOMY PROCEDURE. THE HCP NEEDED TO REMOVE THE TUBE AND RE-INTUBATE WITH ANOTHER DEVICE. THE PATIENT WAS RE-INTUBATED, WHICH DID CAUSE A DELAY AND POTENTIAL COMPLICATION TO PATIENT; HOWEVER, THE CASE WENT WELL. THE RED CIRCUIT KEPT SHOWING A CROSS WHEN CONNECTED. THE HCP TRIED THE RED LEAD IN THE BLUE SOCKET AND IT SHOWED A TICK THEN SWAPPED THEM OVER AND SHOWED A CROSS AGAIN PROVING IT WAS THE RED LEAD THAT WAS FAULTY. THERE WAS A NO "ELECTRODE OFF" SHOWED AT ANY TIME.

  Patient problems: Extubate

  MAUDE report 7820153 ↗

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