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

Model Number	I7
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturing date is unavailable.The suspect frame was returned to the manufacturer for analysis.The frame was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.
Event or Problem Description
A medtronic representative reported that, while in a cranial resection, an imprecision occurred during the procedure.It was reported that the surgeon placed the reference frame 180 degrees opposite the direction it was attached for registration.The surgeon unsuccessfully attempted to place a catheter into the ventricle.Once the orientation of the frame was resolved, the surgeon successfully placed the catheter with navigation.Towards the end of the procedure, the surgeon was unable to use navigation as the brain had swelled too much and would have been inaccurate.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no reported impact on patient outcome.No additional information was provided.

• 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: 6622946
• Report Number: 1723170-2017-02400
• Device Sequence Number: 13639923
• Product Code: HAW
• UDI-Device Identifier: 00613994110831
• UDI-Public: 00613994110831
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,user f
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 06/08/2017

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: Physician
• Device Model Number: I7
• Device Catalogue Number: 9732585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 06/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 59