MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION COMPACT; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9735602

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Patient Involvement (2645)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

No products have been returned to medtronic for analysis.Codes 4114, 3221, and 4315 are applicable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system.It was reported that the software would become unresponsive and require a reboot.This was reported outside of a procedure.There was no patient involved.

Manufacturer Narrative

H2/h3/h6: the system was serviced in the field.The system passed all tests and was performing as intended.No failures were found.Codes 10, 213 and 67 are applicable.H2: additional information was received.B5 has been updated.Section e and g3 has been updated to reflect the initial reporter.D11: section d information references the main component of the system.Other relevant device(s) are: software: fusion compact 1.0 9735638 software version: 1.0.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.

Event Description

Additional information was received.The cause was not determined as the issue was not replicated.The representative noticed there was another exam after the one that was reported and no issues occurred during that exam.It was confirmed that it was unknown if a reboot resolved the issue.The resolution was unknown.

Manufacturer Narrative

H2, h3: software analysis determined that there was insufficient information to determine whether a software anomaly contributed to the issue.Previously reported codes 10, 213, and 4315 are applicable.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: FUSION COMPACT
• Type of Device: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10296010
• MDR Text Key: 199515507
• Report Number: 1723170-2020-01961
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• PMA/PMN Number: K153247
• 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: 10/15/2020

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
• Device Operator: Health Professional
• Device Model Number: 9735602
• Device Catalogue Number: 9735602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 07/20/2020; 10/13/2020
• Supplement Dates FDA Received: 08/03/2020; 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10