N/A 945EEX901Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169071865), received between Nov 12, 2018 and Apr 24, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (3 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Device Sensing Problem

  IT WAS REPORTED THAT INTRA-OP, LEFT PORT IN ROW 1 STOPPED  WORKING AND PROGRAMMING WAS CHANGED TO ROW 2 AND WORKED FOR SEVERAL MINUTES THEN ALL PORTS STOPPED WORKING.  A SECOND STIM BOX WAS REPLACED AND ONLY ABOUT 10 MIN OF THE SURGERY WERE SSEPS NOT MONITORED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24975655 ↗
• MalfunctionNov 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DEVICE FAILED THE SELF STIM AND THE RIGHT PORT WAS DAMAGED. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23566207 ↗
• MalfunctionFeb 25, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT PRIOR TO USE, IT WAS FOUND THAT THERE WAS NO SIGNAL AND 2 R BAD. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21455703 ↗
• MalfunctionJul 29, 2022Use of Device Problem; Use of Device Problem

  IT IS REPORTED THAT DEVICE EXPERIENCING COMPLETE FAILURE. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136227 ↗
• MalfunctionSep 12, 2019Break; Intermittent Continuity; Device Sensing Problem; Noise, Audible; Break; Intermittent Continuity; Device Sensing Problem; Noise, Audible

  A HEALTH CARE PROVIDER REPORTED THAT THE DEVICE GET INTERMITTENT MILD NOISE AGAIN AND THE MEP (MOTOR EVOKED POTENTIALS) FUNCTION DOES NOT SEEM TO WORK ALL THE TIME. SWITCHED PORT FOR MEP FROM THE LEFT TO RIGHT BUT HAVEN'T MONITORED ENOUGH CASES NEEDING MOTORS TO DETERMINE IF THAT IS REALLY THE PROBLEM. AT THE START OF CASES, ABLE TO ELICIT MEPS BUT AT THE END NOTHING WAS RECORDED. NOW, THE HCP WAS HEARING SOMETHING INSIDE THE BOX RATTLING; SOMETHING WAS BROKEN. THE PROBLEM HAS OCCURRED INTERMITTENTLY. THERE WAS NO IMPACT ON PATIENT OR SURGEON. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PORT WAS CHANGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9005697 ↗
• MalfunctionNov 12, 2018Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE AMPLIFIER AND STIMULATORS WERE NOT WORKING. THERE WAS NO KNOWN PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8061505 ↗