MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9735665
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735943, serial/lot #: (b)(6): product id: 9735772, serial/lot #: (b)(6): h3, h6: a manufacturer representative went to the site to test the equipment.In summary, a system checkout was performed.The system did not perform as intended and the hardware parts were replaced.Codes fdm b01, fdr c13, fdc d02 are applicable to this analysis.D9, h2, h3, h6: the hardware was returned and analysis was performed.The reported complaint ¿the umbilical cord was frayed and the internal wires were exposed¿ was able to be confirmed.The returned interconnect cable was found to have multiple tears and damage across the cable, with exposed wires.Despite the damage the cable was found to be functional.Codes fdm b01, fdr c0201, and fdc d02 are applicable to this analysis.D9, h2, h3, h6: the hardware was returned and analysis was performed.The reported complaint ¿the power cord had several large scuffs and wear marks¿ was able to be confirmed.The returned power cable was torn up but there weren't any exposed wires.Despite the damage, the cable was found to be fully functional.Codes fdm b01, fdr, c0201, and fdr d02 are applicable to this analysis.Multiple fdd/annex a codes were reported.A040507 was coded for the wear marks.A07 was coded for internal wires being exposed in the umbilical cord.A05 was coded for the umbilical cord being frayed.H6: multiple annex g codes were reported.G02004 corresponds to concomitant product cable (9735772) that comprises the reported event.G02026 corresponds to concomitant product power cord (9735943) that comprises the reported event.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that while replacing the monitor for a related case, the medtronic representative found that the umbilical cord was frayed and the internal wires were exposed.Additionally, the power cord had several large scuffs and wear marks.These cords have never been replaced in this system's history.Technical services believed this was due to normal wear and tear.There was no patient involvement.

• Brand Name: STEALTHSTATION¿ S8 SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 24932211
• Report Number: 1723170-2026-00629
• Device Sequence Number: 5180529
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: (01)00643169722187(11)181018
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K162309
• 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): 04/20/2026

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: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Sex: Unknown