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

Model Number	9733560
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Concomitant medical products: other relevant device(s) are: product id: 960-152, version #: 3.17.The software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding the navigation system.It was reported that some korean domestic cone beam ct (pointnix, hdx) are not compatible with medtronic navigation somehow, especially fusion and fusion compact, so that demonstration was not able to proceed.The system showed 'no image loaded'.Even though the manufacturer representative (rep) checked it contains one x-ray image, the rep was not able to find the main reason why it does not load in the old system.The issue has not been resolved yet.Additional information received from a manufacturer representative indicated no further actions would be taken.It was confirmed the site that the navigation system in question was not compatible because of the program setting (media io).

• Brand Name: FUSION® ENT NAVIGATION SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13254157
• Report Number: 1723170-2022-00058
• Device Sequence Number: 14598561
• Product Code: HAW
• UDI-Device Identifier: 00763000235079
• UDI-Public: 00763000235079
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K001284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2022

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
• Operator of Device: Health Professional
• Device Model Number: 9733560
• Device Catalogue Number: 9733560
• Device Lot Number: N08203999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown