MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 NAVIGATION; INSTRUMENT, STEREOTAXIC

Model Number	9734685
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: 9733571, serial/lot #: (b)(4).A representative went out to the site to preform a system check out.It was noted that there wer parts replaced and the system preformed as intended.The monitor to monitor cable was returned and analysis was completed.The preformed a continuity test revealed an open in the cable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Hold for ab 11.12 medtronic received information regarding a navigation system that was used outside of procedure.It was reported that while on site, it was noticed that the surgeon monitor had a buzzing noise.Based on previous cases, probable cause was determined to be likely due to the cart to cart cable connection.No patient present.(b)(6) 2020 (rep): it was reported that the cable was the cause of the buzzing noise associated with the monitor.It was replaced.

• Brand Name: STEALTHSTATION S7 NAVIGATION
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10824469
• Report Number: 1723170-2020-02964
• Device Sequence Number: 14207236
• Product Code: HAW
• UDI-Device Identifier: 00613994806604
• UDI-Public: 00613994806604
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

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: No Information
• Device Model Number: 9734685
• Device Catalogue Number: 9734685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1