MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION(TM) S7(R); INSTRUMENT, STEREOTAXIC

Model Number	9734048
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the 9735585 found an import failure.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system while outside of procedure.It was reported that when attempting to export an archive, the export fails.This occurred because as cranial packaged the original digital intercommunication of medicine (dicom) to be included in the export, that original digital intercommunication of medicine (dicom) contained a private philips scanner, which navigation system does not support.The user was able to export the dataset from the navigation system via the network but no cd/dvd/usb.There was no patient present when the issue occurred.

• Brand Name: STEALTHSTATION(TM) S7(R)
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8701866
• Report Number: 1723170-2019-03357
• Device Sequence Number: 2017543
• Product Code: HAW
• UDI-Device Identifier: 00613994532398
• UDI-Public: 00613994532398
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2019

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: 9734048
• Device Catalogue Number: 9734048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1