NA EEX901 (UDI 00613994910998)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00613994910998), received between Jun 27, 2019 and Aug 7, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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, 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE STIM WAS NOT WORKING AND KEEP APPEARING "ELECTRICAL STIMULATOR EXTENDER MODULE NOT FOUND OR CHECK CONNECTIONS OR REPLACE THE MODULE". THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22736248 ↗
• MalfunctionNov 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, STIM EXTENDER WAS NOT WORKING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20618876 ↗
• MalfunctionDec 25, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT STIMULATOR WAS DEFECTIVE. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18390437 ↗
• MalfunctionJan 20, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DEVICE WAS NOT WORKING PROPERLY. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213048 ↗
• MalfunctionAug 4, 2021Use of Device Problem; Use of Device Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE EXTENDER WAS FAULTY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12274275 ↗
• MalfunctionJun 21, 2021Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT HCP HAD A TECHNICAL ISSUES THAT IS WHY THEY SWITCHED THE DEVICE. THEY CHANGE THE LAPTOP'S DAMAGED SOFTWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12035637 ↗
• MalfunctionMar 13, 2020Use of Device Problem; Use of Device Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE STIMULATOR WAS DEFECTIVE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9829208 ↗
• MalfunctionNov 8, 2019Unable to Obtain Readings; Unable to Obtain Readings

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE DEVICE DOES NOT RECOGNIZE THE AMPLIFIER, IT CANNOT MONITOR. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9296375 ↗
• MalfunctionOct 7, 2019Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE STIMULATOR EXTENDER WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9161147 ↗
• MalfunctionSep 23, 2019Use of Device Problem; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE STIMULATOR EXTENDER WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9104096 ↗
• MalfunctionJun 27, 2019Device Sensing Problem; Device Sensing Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE STIMULATOR EXTENDER WAS NOT RESPONDING. THERE WAS NO KNOWN PATIENT IMPACT REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8739483 ↗