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

Model Number	9733534XOM
Medical Device Problem Codes	Communication or Transmission Problem (2896); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient tracker instrument was returned to the manufacturer for analysis.The returned tracker is recognized but does not track, displaying only red status when connected to a known good system.A check of the em interface showed that coil #1 was not firing.The hardware investigation found that the reported event was related to a hardware issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess).It was reported that the system would not recognize multiple patient trackers.He was in a facetime call with the facility at the time.He saw that the emitter details showed it was connected but was not giving any value.There was a reported delay of less than one hour and no reported impact to patient outcome.Additional information received.The manufacturer representative was on site and was able to get a nipt tracking with no issue.The head frame patient tracker was only working intermittently.Em interface showed that coil 1 of the patient tracker was intermittently not getting picked up, but coil 2 and 3 were working.Site reuses the patient trackers.Site was informed that the instrument is not intended for more than one use and issue would likely not occur again.

• Brand Name: FUSION ENT NAVIGATION SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10135833
• Report Number: 1723170-2020-01624
• Device Sequence Number: 17097778
• Product Code: HAW
• UDI-Device Identifier: 00613994380029
• UDI-Public: 00613994380029
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K001284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2019
• Device Model Number: 9733534XOM
• Device Catalogue Number: 9733534XOM
• Device Lot Number: 170520C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 98