MAUDE Adverse Event Report: STEALTHSTATION® S7¿; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9733856

Device Problems Display or Visual Feedback Problem (1184); Mechanical Problem (1384)

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

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 9735225, serial/lot #: (b)(4).A manufacturer representative went to the site to test the equipment.It was noted that hardware parts were replaced.The navigation system then passed the system checkout and was found to be fully functional.The computer was returned to the manufacturer for analysis.Analysis found that the computer storage was not functioning/malfunctioning.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used for an unknown procedure.It was reported that the monitors went black while setting up for a case.It was noted that the site tried multiple reboots and eventually the system booted up, but the surgeon decided to postpone the case.The site also reported that they could hear the fans of the computer.It was noted that navigation was aborted.There was less than an hour delay to the procedure and no reported impact to patient outcome.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that the issue was pre-op to a tumor resection, and the patient was never brought in.The system was working then both monitors failed.It was reported to be a computer failure.

• Brand Name: STEALTHSTATION® S7¿
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• MDR Report Key: 12587152
• MDR Text Key: 275141433
• Report Number: 1723170-2021-02447
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

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
• Device Operator: Health Professional
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 10/14/2021
• Supplement Dates FDA Received: 11/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1