NIM-ECLIPSE® ECLC (UDI 00613994910967)Recalls & reported problems
Medtronic Xomed, Inc. · CONTROLLER ECLC ECLIPSE · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medtronic NIM ECLIPSE nerve monitoring controller, used during spine surgery to check nerve function and help guide the operation. The 35 reports mostly describe the unit not working or not connecting to its laptop or stimulation box, with error messages and the controller dropping out during procedures. No deaths or injuries were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00613994910967), received between Dec 11, 2017 and Mar 10, 2025 — classified as 35 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (26 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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem26
- Unable to Obtain Readings4
- Device Sensing Problem2
- Failure to Sense2
- Incorrect, Inadequate or Imprecise Result or Readings2
- Adverse Event Without Identified Device or Use Problem1
- Connection Problem1
- Display or Visual Feedback Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Consequences Or Impact To Patient11
- No Known Impact Or Consequence To Patient3
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem
IT WAS REPORTED THAT PRE-OP, CONTROLLER NOT COMMUNICATING WITH LAPTOP. NIM ECLIPSE CONTROLLER NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21556862 ↗MalfunctionMar 3, 2025Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT MACHINE WAS NOT STIMULATING BEFORE THE OPERATION. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21502631 ↗MalfunctionNov 7, 2024Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE NIM ECLIPSE DEVICE HAD AN ISSUE WITH THE CONNECTIVITY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20627292 ↗MalfunctionAug 13, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED DURING CERVICAL SPINE DISK RESECTION PROCEDURE THAT THE PHYSICIAN WAS TRYING TO STIMULATE TO ELICIT MOTOR EVOKED POTENTIALS (MEP) WHEN POP-UP WINDOW OCCURRED ON SCREEN SAYING THAT STIMULATION BOX CANNOT BE FOUND. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19971867 ↗MalfunctionJul 26, 2024Display or Visual Feedback Problem; Use of Device Problem; Display or Visual Feedback Problem; Use of Device Problem
IT WAS REPORTED THAT DURING PRE-CHECK, DEVICE WAS NOT WORKING, SHOWING ERROR MESSAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NIM ECLIPSE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19842636 ↗MalfunctionJul 9, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT NIM CONTROLLER WAS MALFUNCTIONING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19699496 ↗MalfunctionJan 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem
IT WAS REPORTED THAT THE CONTROLLER WAS NOT WORKING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18461785 ↗MalfunctionDec 26, 2023Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE ECLC CONTROLLER WAS DEFECTIVE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18391325 ↗MalfunctionOct 30, 2023Use of Device Problem; Key or Button Unresponsive/not Working; Use of Device Problem; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT NIM ECLIPSE NOT WORKING. THERE IS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18030799 ↗MalfunctionOct 10, 2023Unable to Obtain Readings; Unable to Obtain Readings
IT IS REPORTED THAT DURING USE, DEVICE HAS CONNECTION ISSUE. THERE IS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17903192 ↗MalfunctionApr 18, 2023Use of Device Problem; Use of Device Problem
ADDITIONAL INFORMATION RECEIVED, DEVICE WITH THE NEW LAPTOP STARTED BEHAVING BADLY. AFTER 5-20 MINUTES FROM THE START OF THE DEVICE, THE ECDL DISCONNECTS AND IT IS NECESSARY TO RESTART THE DEVICE. THIS HAPPENS REPEATEDLY DURING THE OPERATION, AT INTERVALS OF MINUTES/TENS OF MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16759441 ↗MalfunctionDec 19, 2022Intermittent Continuity; Impedance Problem; Intermittent Continuity; Impedance Problem
IT WAS REPORTED THAT THE CONTROLLER WAS WORKING INTERMITTENTLY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16002866 ↗MalfunctionAug 23, 2022Unable to Obtain Readings; Unable to Obtain Readings
A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE DEVICE HAD NO STIMULATION RESPONSE/THE CONTROL UNIT REPORTS "ERROR STIMULATING PART. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15276463 ↗MalfunctionApr 2, 2022Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING AND THE ISSUE WAS UNSPECIFIED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13992281 ↗MalfunctionAug 5, 2021Use of Device Problem; No Apparent Adverse Event; Use of Device Problem; No Apparent Adverse Event
A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE CONTROLLER WAS NOT WORKING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12281779 ↗MalfunctionJul 27, 2021Use of Device Problem; Connection Problem; Use of Device Problem; Connection Problem
A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE LOWER PART ON THE RIGHT SIDE NO LONGER WORKS. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12229568 ↗MalfunctionMay 11, 2021Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THE DEVICE HAS INCONSISTENT RESPONSE. ALTHOUGH THERE WERE NO NEUROLOGICAL DEFICITS IN THE PATIENTS AND THERE WAS NO FACTOR AFFECTING THE SYSTEM (ANESTHETIC, SETUP, ETC.), NEUROPHYSIOLOGICAL RESPONSES EXPECTED FROM PATIENTS COULD NOT BE OBTAINE D IN BOTH SURGERIES. THERE WERE DIFFERENCES BETWEEN THE PATIENT'S NEUROLOGICAL EXAMINATION AND THE RESPONSES OF THE DEVICE. IT WAS NOTED THAT THE MALFUNCTION HAPPENED WHEN USING ON PATIENT (INTRA-OPERATIVELY). FOR TROUBLESHOOTING, THE WHOLE SYSTEM WAS CHECKED, BUT COULD NOT FIND WHAT WAS WRONG WITH THE DEVICE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11805575 ↗MalfunctionMay 10, 2021Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THE DEVICE HAS INCONSISTENT RESPONSE. ALTHOUGH THERE WERE NO NEUROLOGICAL DEFICITS IN THE PATIENTS AND THERE WAS NO FACTOR AFFECTING THE SYSTEM (ANESTHETIC, SETUP, ETC.), NEUROPHYSIOLOGICAL RESPONSES EXPECTED FROM PATIENTS COULD NOT BE OBTAINED IN BOTH SURGERIES. THERE WERE DIFFERENCES BETWEEN THE PATIENT'S NEUROLOGICAL EXAMINATION AND THE RESPONSES OF THE DEVICE. IT WAS NOTED THAT THE MALFUNCTION HAPPENED WHEN USING ON PATIENT (INTRA-OPERATIVELY). FOR TROUBLESHOOTING, THE WHOLE SYSTEM WAS CHECKED, BUT COULD NOT FIND WHAT WAS WRONG WITH THE DEVICE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11799201 ↗MalfunctionApr 21, 2021Use of Device Problem; Use of Device Problem
ON FOLLOW UP, THE MANUFACTURER REPRESENTATIVE CONFIRMED THAT AT THE END, THE DEVICES WERE ACTUALLY WORKING, AND THEY DIDN'T NEED TO REPLACE ANY PIECE OR COMPONENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11700529 ↗MalfunctionDec 28, 2020Use of Device Problem; Use of Device Problem
A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE CONTROLLER WAS NOT WORKING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11076488 ↗MalfunctionNov 24, 2020Sensing Intermittently; Use of Device Problem; Device Sensing Problem; Sensing Intermittently; Use of Device Problem; Device Sensing Problem
A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE CONTROLLER WAS NOT WORKING AND INTERMITTENT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10895481 ↗MalfunctionJul 29, 2020Use of Device Problem; Use of Device Problem
IT WAS REPORTED VIA HEALTH CARE PROFESSIONAL THAT THE DEVICE WAS DEFECTIVE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10337056 ↗MalfunctionApr 4, 2020Use of Device Problem; Use of Device Problem
A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE CONTROLLER WAS NOT WORKING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9925880 ↗MalfunctionMar 17, 2020Use of Device Problem; Use of Device Problem
A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE DEVICE WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9840843 ↗MalfunctionDec 27, 2019Use of Device Problem; Use of Device Problem
A HEALTH ARE PROVIDER (HCP) REPORTED THAT A DEVICE WAS NOT WORKING PROPERLY AFTER USE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9523076 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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