MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION ENT NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9733560

Device Problems Electrical /Electronic Property Problem (1198); Temperature Problem (3022); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.The unique identifier was not available at the time of reporting.Concomitant medical products: product id: 9733361, lot/serial #: unknown.The manufacturer representative went to the site to test the navigation system.The computer boot-up failed.The isolation trans former was defective and needed to be replaced.However, the system will not be repaired because it has reached end of life.The manufacture date was not available at the time of reporting.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that the navigation system would not start up.It was reported that the fuses were "burning".There was no patient present when this issue was identified.Additional information was received stating that the isolation transformer was defective and needed to be replaced.However, the system will not be repaired because it has reached the end of life for it.

Manufacturer Narrative

H6: additional information: device code a10 is no longer applicable to this event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information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 from the manufacturer representative.It was reported that the fuses were blowing and not burning.The manufacturer representative stated that it looked like the transformer had a short circuit.

• Brand Name: FUSION ENT NAVIGATION SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11444833
• MDR Text Key: 238933404
• Report Number: 1723170-2021-00623
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733560
• Device Catalogue Number: 9733560
• Device Lot Number: 4500514288
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."