MAUDE Adverse Event Report: COVIDIEN BIS; ELECTRODE, CUTANEOUS

Model Number	186-0106
Medical Device Problem Codes	High Readings (2459); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the sensor did not communicate, and the patient was under general anesthesia.The anesthesia depth monitor was set up before induction.However, before the incision, it indicated a value of 85, despite a propofol target of 10 in tci mode.Theelectroencephalogram (eeg) tracing showed an almost flat curve, which indicated a discrepancy between the displayed value and the tracing.After changing the sensor, the same data was returned.A third sensor was then used.The event resulted to excessively deep anesthesia and required catecholamines because of the anesthesia doses given.
Additional Manufacturer Narrative
Concomitant product: 186-0106 186-0106 quatro sensor x25 lot# 0313251l pli 10 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that it was reported that the sensor did not communicate, and the patient was under general anesthesia.The anesthesia depth monitor was set up before induction.However, before the incision, it indicated a value of 85, despite a propofol target of 10 in tci mode.The electroencephalogram (eeg) tracing showed an almost flat curve, which indicated a discrepancy between the displayed value and the tracing.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: BIS
• Common Device Name: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): COVIDIEN; 6135 gunbarrel ave; boulder CO 80301
• Manufacturer (Section G): COVIDIEN; 6135 gunbarrel ave; boulder CO 80301
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23401442
• Report Number: 2936999-2025-00527
• Device Sequence Number: 9945615
• Product Code: GXY
• UDI-Device Identifier: 20884521134307
• UDI-Public: (01)20884521134307(17)260913(10)0313251L(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K143506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2026
• Device Model Number: 186-0106
• Device Catalogue Number: 186-0106
• Device Lot Number: 0313251L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTES ON H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown