MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S8 ENT; INSTRUMENT, STEREOTAXIC

Model Number 9735669

Device Problem Imprecision (1307)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation has not been done at the time of submitting this report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery.It was reported that the surgeon felt a few millimeters inaccurate at the skull base.The surgeon stated that the depth was off, but that he felt accurate laterally.The surgeon went back and re-registered the patient but felt inaccurate again.It was also stated that when the surgeon went into the registration screen, the 3d registration model needed to be adjusted a lot because there were lines running through it.There was a procedure delay of less than one hour and no impact to the patient.

Manufacturer Narrative

H3: a software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

2020-mar-12.(b)(4): medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery.It was reported that the surgeon felt a few millimeters inaccurate at the skull base.The surgeon stated that the depth was off, but that he felt accurate laterally.The surgeon went back and re-registered the patient but felt inaccurate again.It was also stated that when the surgeon went into the registration screen, the 3d registration model needed to be adjusted a lot because there were lines running through it.There was a procedure delay of less than one hour and no impact to the patient.It was reported that no exact cause could be determined but adding more coverage to the previous registration helped make it feel more accurate, but still not 100% according to surgeon.The surgeon did not know the exact inaccuracy.

Manufacturer Narrative

H2/h3/h6: the system was serviced in the field and no failures were found.The system was performing as intended.Codes 10, 213 and 67 are applicable.H2/d10: software logs have been received but analysis has not been done at the time of submitting this report.D11/h2: section d information references the main component of the system.Other relevant device(s) are: software: sw app 9735762 stealth s8 app software version: 1.2.0 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: S8 ENT
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9835362
• MDR Text Key: 183566055
• Report Number: 1723170-2020-00901
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00643169838918
• UDI-Public: 00643169838918
• Combination Product (y/n): N
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735669
• Device Catalogue Number: 9735669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Age: 71 YR
• Patient Weight: 79