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

Model Number 9733856

Device Problems Display or Visual Feedback Problem (1184); Mechanical Jam (2983); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735672.H6: no hardware parts have been returned for analysis.B17, c20, d15 are applicable.H6: multiple fdd/annex a codes were reported.A0506 was coded for the cd/drive being jammed.A0902 was coded for the monitor remaining black.A110201 was coded for the no signal message.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that when booting the system the staff monitor displayed a "no signal" message and the surgeon monitor stayed blank.The manufacturer representative was not able to open/close the cd drive.Technical services (ts) asked the manufacturer representative to reset complementary metal-oxide semiconductor (cmos) battery, system booted as intended.The most likely / suspected cause of the issue was the cmos battery. there was no patient involvement.

Manufacturer Narrative

H3, h6: the system was serviced in the field and the hardware part was replaced.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: STEALTHSTATION® S7¿
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18962732
• MDR Text Key: 338456111
• Report Number: 1723170-2024-00886
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/15/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1