MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC WRKSTN, 9732585, STLTHSTN INAV II; INSTRUMENT, STEREOTAXIC

Model Number	9732585
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	02/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was refused by the site.A medtronic representative went to the site to test the equipment.Testing revealed that the system was functioning as intended.The system passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a cranial biopsy procedure.It was reported that during biopsy procedure the site used magnetic resonance imaging (mr) to plan and perform navigation.A post-op computed tomography (ct) was merged with the mr and showed a 5mm deviation from the planned target.There was no patient impact reported and no delay to surgery.
Additional Manufacturer Narrative
This event resulted in inconclusive biopsy results.The patient had to schedule a new biopsy.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
A software analysis was initiated to determine the probable cause of the issue through reproducibility.Analysis was unable to determine probable cause without further information since the on-going investigation proved to be inconclusive based on the information provided.If information is provided in the future, a supplemental report will be issued.

• Brand Name: WRKSTN, 9732585, STLTHSTN INAV II
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8387768
• Report Number: 1723170-2019-00906
• Device Sequence Number: 19281511
• Product Code: HAW
• UDI-Device Identifier: 00613994110831
• UDI-Public: 00613994110831
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2019

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: 9732585
• Device Catalogue Number: 9732585
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 02/18/2019; 06/07/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 03/04/2019; 06/19/2019
• 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: Required Intervention