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

Model Number	PMPAMP71
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use, the devices had reading issue.It was stated that the monitor showed low baseline and erratic rso2 reading fluctuating by 40-50% from baseline unilaterally and on both sides.It was stated that first baselines were 20 and 24.Sensors were removed and new ones applied resulting in baselines of 28 and 30.Baselines reading were set on an awake patient receiving 6 lpm of oxygen.It was reported that there was no patient injury.
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.
Event or Problem Description
According to the reporter, during use, the devices had reading issue.It was stated that the monitor showed low baseline and erratic rso2 reading fluctuating by 40-50% from baseline unilaterally and on both sides.It was stated that first baselines were 20 and 24.Sensors were removed and new ones applied resulting in baselines of 28 and 30.Baselines reading were set on an awake patient receiving 6 lpm of oxygen.The customer reported that there was no patient injury.

• 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: 8422609
• Report Number: 2936999-2019-00187
• Device Sequence Number: 239966
• Product Code: MUD
• UDI-Device Identifier: 10884521552616
• UDI-Public: 10884521552616
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K182868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024
• 2 Devices were Involved in the Event: 1 2

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 08/12/2024
• 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: 60 YR
• Patient Sex: Male