MAUDE Adverse Event Report: MEDTRONIC NAVIGAITON, INC. FUSION COMPACT; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number	9735602
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturer representative went to the site to test the navigation system.The reported issue could not be confirmed.A system checkout was performed and the system is working as intended.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 in a functional endoscopic sinus surgery (fess).It was reported that the health care professional (hcp) had a registration that they were satisfied with, on the anterior aspect of the patient.As the hcp got to the sphenoid they used an ostiem seeker and caused a cerebrospinal fluid (csf) leak.The hcp consulted with other hcp and stopped the csf leak.The hcp proceeded with the procedure.There was less than an hour delay in the procedure.No impact on patient outcome.

• Brand Name: FUSION COMPACT
• Common Device Name: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGAITON, INC.; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8249898
• Report Number: 1723170-2019-00259
• Device Sequence Number: 1582545
• Product Code: PGW
• UDI-Device Identifier: 00643169672956
• UDI-Public: 00643169672956
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153247
• 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): 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9735602
• Device Catalogue Number: 9735602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Weight: 118