NA EEX901 (UDI 00643169378483)Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00643169378483), received between Jul 11, 2017 and Jul 1, 2026 — classified as 66 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (37 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Use of Device Problem

  IT WAS REPORTED THAT PRE-OP, THE STIMULATOR WAS NOT WORKING PROPERLY. THE PROCEDURE WAS COMPLETED WITH THE OTHER STIMULATOR BOX. THE RE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25676732 ↗
• MalfunctionJun 17, 2026Use of Device Problem

  IT WAS REPORTED THAT BEFORE OPERATION, NIM ECLIPSE WAS NOT WORKING PROPERLY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25529584 ↗
• MalfunctionJun 12, 2026Display or Visual Feedback Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING TESTING; THE STIMULATOR EXTENDER WAS NOT WORKING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25482096 ↗
• MalfunctionApr 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION RECEIVED THAT THE ISSUE WAS NOTICED DURING THE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954161 ↗
• MalfunctionMar 24, 2026Unable to Obtain Readings

  IT WAS REPORTED THAT PRE-OP, THE MACHINE DOESN'T WORK AFTER BEING TURNED ON, THERE WAS NO STIMULATION RESPONSE. THE ISSUE WAS NOT RESOLVED WITH REPOSITIONING OR TROUBLESHOOTING. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672057 ↗
• MalfunctionMar 16, 2026Use of Device Problem

  IT WAS REPORTED THAT BEFORE OPERATION, THE STIMULATOR EXTENDER WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24611200 ↗
• MalfunctionJan 24, 2026Connection Problem

  IT WAS REPORTED THAT PRE-OPERATION, NIM STIMULATOR WAS NOT COMMUNICATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24173445 ↗
• MalfunctionDec 18, 2025Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED, THERE WERE NO ISSUES WITH SIMULATOR, ONLY THE HANGAR WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836703 ↗
• MalfunctionDec 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USAGE, THE NIM ECLIPSE EXTENDER STIMULATOR WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826251 ↗
• MalfunctionNov 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRE-OP, THE ENTIRE NIM SETUP DOES NOT WORK. INITIALLY THERE WAS A PROBLEM WITH THE CABLE FROM THE STIMULATOR EX TENDER, IT HAD DAMAGED PINS AND THE STIMULATOR WAS NOT WORKING. THE CABLE WAS REPLACED TOGETHER WITH ANOTHER STIMULATION BOX BUT THE STIMULATOR STILL DID NOT WORK. AND ON THE NIM SCREEN THE ERROR APPEARED: ELECTRO STIMULATOR MODULE FAILURE: 0X00-ST. THERE WAS NO P ATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566336 ↗
• MalfunctionNov 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING START OF A CASE, USER TRIED TO SETUP NIM ECLIPSE BUT IT DID NOT WORK SO WHILE CONNECTING THE NEEDLES INTO THE PATIENT, USER RESTARTED THE COMPUTER TO SEE IF IT WOULD WORK AND IT DID NOT WORK. THERE WAS A CONSTANT ERROR ON THE SCREEN SAYING ¿SELF-TEST INDICATES AN OUTPUT FAILURE. AS WELL AS SAYING MULTIPLE INSTANCES DETECTED, STIMULATION MODE AND THE WHOLE COMPUTER WOULD SHUT DOWN THERE AFTER THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507797 ↗
• MalfunctionOct 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PRE-OP, THE STIMULATOR EXTENDER WAS NOT WORKING PROPERLY, HAD ELECTRIC FAULT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348046 ↗
• MalfunctionOct 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE OUTPUTS ARE NOT PRODUCING A STABLE OUTPUT IN STIMULATOR EXTENDER, THE MEASURED CURRENT IS VERY VARIABLE, ACROSS ALL CHANNELS AND IN SOME CASES NO OUTPUT IS PRODUCED. USER REPLACED THE BOX AND THE SECOND BOX WORKED AS INTENDED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23320747 ↗
• MalfunctionSep 8, 2025Intermittent Loss of Power; Intermittent Loss of Power

  IT WAS REPORTED THAT PRE OP, STIMULATOR MODULE NOT FOUND. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22989992 ↗
• MalfunctionAug 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE OPERATION, THE IMPEDANCE VALUE DISPLAYS AN ERROR AND DOES NOT WORK PROPERLY. THE ISSUE WAS NOT RESOLVED BY TROUBLESHOOTING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881847 ↗
• MalfunctionAug 12, 2025Use of Device Problem; Device Sensing Problem; Use of Device Problem; Device Sensing Problem

  IT WAS REPORTED THAT PRE-OP, THE STIMULATOR WAS NOT WORKING PROPERLY. SIGNALS ARE OFTEN UNSTABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22780415 ↗
• MalfunctionAug 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE STIM BOX WAS NOT WORKING AT ALL OR SO SLOW. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22734904 ↗
• MalfunctionJul 18, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT BEFORE OPERATION NIM ECLIPSE SYSTEMS WERE NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540558 ↗
• MalfunctionJul 18, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT BEFORE OPERATION NIM ECLIPSE SYSTEMS WERE NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540534 ↗
• MalfunctionJun 24, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT BEFORE OPERATION THE STIMULATOR EXTENDER WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323058 ↗
• MalfunctionJun 23, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT PRE-OP, NIM STIMULATOR HAD CONNECTION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22305897 ↗
• MalfunctionJun 23, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT PRE-OP, NIM STIMULATOR HAS CONNECTION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22305869 ↗
• MalfunctionApr 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PRE-OP, STIMULATOR EXTENDER 3/4 JACK HAD NO SIGNAL/RESPONSE AFTER PLUGGING IN . ISSUE WAS NOT RESOLVED BY REPOSITIONING/TROUBLESHOOTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21888503 ↗
• MalfunctionApr 4, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING PRE-OP, THE STIMULATOR CANNOT BE IDENTIFIED. ISSUE WAS NOT RESOLVED BY REPOSITIONING/TROUBLESHOOTING THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21770969 ↗
• MalfunctionMar 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER TURNING IT ON, THE HOST COULDN'T DETECT THE ELECTRICAL STIMULATION BOX. AFTER REPEATED TESTS, THE FAULT STILL COULDN'T BE RESOLVED, AND THE DEVICE WAS STOPPED USING. ALSO THE DEVICE COULD NOT RECOGNIZE THE STIMULATOR EXTENDER. THIS DEVICE WAS USED TO DIAGNOSE NERVES DURING BRAIN SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21569732 ↗