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

Model Number 9733857

Device Problem Material Integrity Problem (2978)

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

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

The unique identifier was not available at the time of reporting.The manufacturer representative went to the site to test the navigation system.The issue was confirmed and parts were replaced.The manufacture date was not available at the time of reporting.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used during a cranial biopsy.It was reported that following patient registration, the camera of the navigation system was not working.Connections were verified and the navigation system was restarted without resolution.The surgeon opted to complete the procedure without the use of the navigation system.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no reported impact on patient outcome.

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id: 9733437, lot/serial #: (b)(6) ; product id: 9733438, lot/serial #: (b)(6) the positioning sensor unit (psu) was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was confirmed.The returned psu would not power up on the test bench.This psu has not been previously returned for a failure.B01 c02 d02 the polaris spectra system control unit (scu) was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was not confirmed.The returned scu powered up on the test bench without issue.A check of the event log did not reveal any adverse events.The scu had normal tracking for all instrument ports and a functioning foot switch.No problem found.B01 c19 d14.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.

• Brand Name: STEALTHSTATION S7'
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11057699
• MDR Text Key: 223609746
• Report Number: 1723170-2020-03377
• Device Sequence Number: 1
• Product Code: HAW
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733857
• Device Catalogue Number: 9733857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 80