NA OPM660Recalls & reported problems
Medtronic Xomed, Inc. · MODULE OPM660 PATIENT ROHS · Class 2
Quick summary
This Medtronic OPM660 patient module is an EEG module used to monitor the brain during surgery. Its 101 FDA reports include 1 injury and no deaths, and often describe the module not working as expected, with some reports of breaks and poor readings. One report describes the device stopping during surgery after water got inside the box. Reports fell to 1 in the last 12 months from 26 before. 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
- 101
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 00613994870810), received between Sep 1, 2017 and Mar 10, 2026 — classified as 1 injury, 100 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (68 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 Problem68
- Break15
- Unable to Obtain Readings9
- Incorrect, Inadequate or Imprecise Result or Readings6
- Connection Problem4
- Device Sensing Problem4
- Circuit Failure1
- Computer Software Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions70
- No Consequences Or Impact To Patient29
- No Patient Involvement3
- Sedation1
Recent adverse event reports
The 25 most recent of 101 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING PRE-OP, THE MODULE CURRENT NOT BEING DELIVERED WHEN STIMULATING. MODULE HAD POWER. MODULE TESTED WITH A NOTHER DEVICE AND HAD SAME ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24555722 ↗MalfunctionOct 17, 2025Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT THE STIMULATION BOX OF THE NIM ECLIPSE SYSTEM NO LONGER STIMULATES. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23320353 ↗MalfunctionAug 5, 2025Electrical /Electronic Property Problem; Use of Device Problem; Electrical /Electronic Property Problem; Use of Device Problem
IT WAS REPORTED THAT THE PATIENT MODULE HAD A DEFECT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22712448 ↗MalfunctionJul 15, 2025Break; Break
IT WAS REPORTED THAT DEVICE HAD NON SPECIFIC BROKEN ISSUE. THERE IS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22505708 ↗MalfunctionJul 15, 2025Break; Break
IT WAS REPORTED THAT DEVICE HAD NON SPECIFIED BROKEN ISSUE. THERE IS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22505676 ↗MalfunctionJul 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Shutdown; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Shutdown
ADDITIONAL INFORMATION RECEIVED STATING INTRA-OP, DEVICE SUDDENLY STOPPED WORKING WHILE THEY WHERE MONITORING AN ENDOSCOPIC SURGERY. PROCEDURE WAS COMPLETED WITH BACK-UP PRODUCT. THIS HAPPENED DUE TO SOME WATER ENTERED INSIDE THE BOX.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22490718 ↗MalfunctionJul 10, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT PRIOR TO USE, THE MODULE WAS NOT WORKING PROPERLY. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING OR REPOSITIONING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22466766 ↗MalfunctionMay 26, 2025Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT PRE OP, DEVICE HAD COMMUNICATION ERROR. THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22083161 ↗MalfunctionMay 26, 2025Break; Break
IT WAS REPORTED THAT DURING ENDOSCOPIC SURGERY, THE MODULE BROKEN BY WATER ENTERING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22082950 ↗MalfunctionMay 6, 2025Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT PRE-OP, THE ELECTRODE WHICH IS CONNECTED TO THE LEFT HAND IS NOT WORKING. THERE WERE NO SIGNALS FROM LEFT HAND AND THE OPERATION CONTINUED WITHOUT THE FUNCTIONALITY OF THIS ELECTRODE PLACED ON THE LEFT HAND. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21965364 ↗MalfunctionMay 5, 2025Break; Use of Device Problem; Break; Use of Device Problem
IT WAS REPORTED THAT THERE WAS ISSUE WITH CHANNEL 7 AND 8. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21958532 ↗MalfunctionMay 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRE-OP, CONNECTION FAILURE WITH THE APP THERE WAS NO COMMUNICATION BETWEEN OPM AND ECLC. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21947699 ↗MalfunctionApr 29, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT BEFORE USE IN TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE, THE PATIENT MODULE WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER EQUIPMENT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21925793 ↗MalfunctionMar 24, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT WHEN THE ELECTRODE IS CONNECTED TO THE RIGHT HAND, THE GRAPH IS NOT VALIDATED AND THE PROGRAM CANNOT BE COMPLETED. THERE IS NO PATIENT IMPACT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21675330 ↗MalfunctionMar 18, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DEVICE IS HYPERSENSITIVITY IN CONDUCTION. THERE IS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21630381 ↗MalfunctionMar 7, 2025Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT INTRA-OP, THE DEVICE WAS NOT RECOGNIZED BY CONSOLE. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21547024 ↗MalfunctionMar 4, 2025Use of Device Problem; Device Sensing Problem; Use of Device Problem; Device Sensing Problem
IT WAS REPORTED THAT THE PURPLE AND WHITE ELECTRODES OF THE DEVICE DID NOT WORK, AND THERE WERE RANDOM SIGNAL LOSSES FROM ALL THE ELECTRODES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21512828 ↗MalfunctionMar 3, 2025Break; Break
IT WAS REPORTED THAT THE DEVICE HAD NON-SPECIFIC BROKEN. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21504785 ↗MalfunctionFeb 25, 2025Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT PRE-OP, PATIENT MODULE WAS NOT SHOWING STIMULATION. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21458529 ↗MalfunctionFeb 25, 2025Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT PRE-OP, IT WAS FOUND THAT MODULE WAS NOT DELIVERING CURRENT. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21456911 ↗MalfunctionFeb 25, 2025Unable to Obtain Readings; Unable to Obtain Readings
IT WAS REPORTED THAT PRE-OP, THE PATIENT MODULE WAS NOT DELIVERING CURRENT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21456224 ↗MalfunctionJan 21, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DEVICE WAS NON-SPECIFIC BROKEN. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21195761 ↗MalfunctionJan 5, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT PATIENT MODULE WAS RETURNED WITH ALLEGED DEFECT WITH NO PROPER CUSTOMER COMMENT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21076530 ↗MalfunctionDec 30, 2024Use of Device Problem; Use of Device Problem
ADDITIONAL INFORMATION RECEIVED, THE EVENT OCCURRED PRIOR TO USE. THE PROCEDURE WAS COMPLETED USING ANOTHER NIM ECLIPSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21036613 ↗MalfunctionDec 12, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT MODULE WAS NON-SPECIFIC/ BROKEN. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20910136 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.