MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S7; INSTRUMENT, STEREOTAXIC

Model Number	9733534
Medical Device Problem Codes	No Device Output (1435); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used during a functional endoscopic sinus surgery (fess).It was reported that the instrument tracker had recognition failure.Navigation was aborted and there was a surgical delay of less than one hour.There was no reported impact to patient outcome.
Additional Manufacturer Narrative
The patient tracker was returned to the manufacturer for analysis.Analysis found that when connected to a known good system the returned tracker was recognized and tracked without issue.No problem found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: S7
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; louisville
• MDR Report Key: 7954309
• Report Number: 1723170-2018-05069
• Device Sequence Number: 428439
• Product Code: HAW
• UDI-Device Identifier: 00613994353467
• UDI-Public: 00613994353467
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2018

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: 9733534
• Device Catalogue Number: 9733534
• Device Lot Number: 160407E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1