MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC I7; INSTRUMENT, STEREOTAXIC

Model Number	9734060
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation has not been done at the time of filing this report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system used during a cranial resection.It was reported that the camera on the system was not functioning.The system was beeping but the camera would not connect.Navigation was aborted and the site brought in a different system to complete the case.There was a procedure delay of less than one hour and no impact to the patient.
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 9735346r, serial/lot #: unknown.(b)(4).No parts have been returned to the manufacturer for analysis.If information is provided in the future, a supplemental report will be issued.

• Brand Name: I7
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9968697
• Report Number: 1723170-2020-01242
• Device Sequence Number: 3676251
• Product Code: HAW
• UDI-Device Identifier: 00613994653482
• UDI-Public: 00613994653482
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2020

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: 10/29/2012
• Device Model Number: 9734060
• Device Catalogue Number: 9734060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 84