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

Model Number 9735665

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.The unique identifier was not available at the time of reporting.Other relevant device(s) are: product id: 9735736, version #: (b)(4).Initial reporter not known at the time of reporting.The manufacturer representative went to the site to test the navigation system.The reported issue was not confirmed and no 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 in a procedure.It was reported that the health care professional tried creating checkpoints then moved the patient and went back to the checkpoints and was unable to realign to the checkpoints.Navigation was aborted.No further information was received.

Manufacturer Narrative

H3: a software investigation analysis was initiated to determine the probable cause of the issue through log analysis.Analysis found that the software appeared to be working as designed.Analysis found that the analysis was inconclusive and probable cause was unable to be determined.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

Medtronic received additional information that the procedure type was a posterior fossa craniotomy.There was an approximated ten minute delay to the procedure.There was no reported impact to patient outcome.

Manufacturer Narrative

H2 ) additional information: see a2-a4, b5, and e1.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: S8 PREMIUM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9853727
• MDR Text Key: 184087123
• Report Number: 1723170-2020-00963
• Device Sequence Number: 1
• Product Code: HAW
• 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: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• 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: 03/31/2020
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 72 YR
• Patient Weight: 63