MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INVOS; OXIMETER, TISSUE SATURATION

Model Number	PMPAMP71
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Failure to Analyze Signal (1539)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during use,  the device had an erratic rso2 readings from below 15 to high 50s or no readings.It could not monitor the patient from surgery for coronary artery bypass warm beating. the monitor and preamps and cables were swapped but sensor continued to read erratically.The event result in a delay of the procedure.
Additional Manufacturer Narrative
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 g6 h3 h6 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted without the sensor in question being returned or the invos tablet.The invos pre-amp was connected to the invos test system (2.0) cl:16283 and there were no errors observed after post.A field tester was used as a sensor/simulator to test the pre-amp and during testing the readings remained consistent and there was no sign of erratic readings.The settings on the pre-amp were changed to various settings and the values were observed on the screen.A medical safety assessment was performed for this event.The medical safety assessment concluded.A review of the system logs showed upon review of the task the event and reported severity are labeled events for the product and/or the procedure and are included in the risk management file.It was reported that the device had an erratic rso2 readings from below 15 to high 50s or no readings.The reported issue was not confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: INVOS
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19106651
• Report Number: 2936999-2024-00605
• Device Sequence Number: 7607091
• Product Code: MUD
• UDI-Device Identifier: 10884521810112
• UDI-Public: 10884521810112
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K182868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PMPAMP71
• Device Catalogue Number: PMPAMP71
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 05/04/2024; 07/08/2025
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 05/15/2024; 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 77 KG