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

Model Number	9735670
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 9735820, serial/lot #: unknown.System has not been evaluated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that whenever they connected the active reference frame to the system, they receive a localizer not connected message in the software.When the frame was disconnected, the fault cleared.They were able to plug other active instruments in and track those.There was no patient present when this issue was identified.No additional information was provided.
Additional Manufacturer Narrative
Additional information received : the serial/lot# for product id 9735820 is (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8930717
• Report Number: 1723170-2019-04631
• Device Sequence Number: 19364983
• Product Code: HAW
• UDI-Device Identifier: 00643169722194
• UDI-Public: 00643169722194
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K162309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: 9735670
• Device Catalogue Number: 9735670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 11/03/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1