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

Model Number 9733560

Device Problem Communication or Transmission Problem (2896)

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

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 9734699, serial/lot #: unknown.Information regarding the system checkout was provided.It was reported that the issue was improved by replacing the cd drive.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used pre-operatively to a functional endoscopic sinus surgery (fess) procedure.It was reported that the cd data could not be read.There was no problem with the data for navigation.The patient data used previously also had similar symptoms.The data was able to be read with a usb memory which made the procedure possible.It was suspected that there was a malfunction of the cd/dvd drive.There was no delay and no impact to the patient.

Manufacturer Narrative

H2: correction - initial reporter occupation has been updated.H2/h3: the system was serviced in the field and hardware parts were replaced.As previously reported, the cd drive had been replaced.Previously submitted b01, c07 and d02 codes 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.

Manufacturer Narrative

Lot number of concomitant product: 1014466l112 h3, h6: the cd drive was returned to medtronic for analysis.Testing was conducted and the issue was confirmed.The system was not able to read a known good disk.Fdm b01, fdr c02, and fdc d02 are applicable to the cd drive analysis.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.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 ENT NAVIGATION SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10943469
• MDR Text Key: 219554783
• Report Number: 1723170-2020-03163
• Device Sequence Number: 1
• Product Code: PGW
• 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,Followup
• Report Date: 03/02/2021

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: 9733560
• Device Catalogue Number: 9733560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 11/16/2020; 02/23/2021
• Supplement Dates FDA Received: 12/07/2020; 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1