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

Model Number 9735665

Device Problem Display or Visual Feedback Problem (1184)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 9735795, lot #: unk.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system that was used during a cranial resection procedure.It was reported that the monitor made a noise and then had lines crossing the screen and then the screen went black.There was still power to the rest of the camera cart.The site continued the case without the monitor.Reboots after the case did not resolve the black monitor.There was no reported delay or known impact on patient outcome.

Manufacturer Narrative

H2: it was reported that there was nothing wrong with the cord that was replaced during system service.It was an older model of monitor, and the newer models have a different cable.There was nothing wrong with the cable itself.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.

Manufacturer Narrative

H2: b5 was updated accordingly.Part number: 9735795, lot number: 18121358, h3: a representative went to the site to preform system check out.It was noted that the camera cart monitor would not turn on.They replaced the camera cart monitor and one cord and the issue was resolved.The monitor was returned and it was noted that the returned monitor had a blank display when connected to a known good system.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.

Event Description

The potential cause was that the monitor just truly went out.As everything else on the camera cart was functioning within normal parameters.

• Brand Name: STEALTHSTATION S8 SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10829557
• MDR Text Key: 215962940
• Report Number: 1723170-2020-02970
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• Combination Product (y/n): N
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10".; SEE H10.
• Patient Age: 13 YR
• Patient Weight: 39