MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) WRKSTN, 9732585, STLTHSTN INAV II; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	I7
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have been returned to the manufacturer for analysis.System scrapped.
Event or Problem Description
It was reported that there was damage to the monitor.As the representative was pulling the unit away, the monitor came off the hinge and fell on the table, which damaged it.

• Brand Name: WRKSTN, 9732585, STLTHSTN INAV II
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7894515
• Report Number: 1723170-2018-04776
• Device Sequence Number: 16584025
• Product Code: HAW
• UDI-Device Identifier: 00613994110831
• UDI-Public: 00613994110831
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/20/2018

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: I7
• Device Catalogue Number: 9732585
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1