MAUDE Adverse Event Report: MEDTRONIC NAVIGATION ISRAEL, LTD POLESTAR N30 SURGICAL MRI SYSTEM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 9734070

Device Problem Computer Software Problem (1112)

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

Event Date 09/27/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Unique device identifier (udi) is unavailable.No additional information has been provided/submitted to the manufacturer for an evaluation to be conducted.Device manufacture date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that, while in a cranial resection, the navigation system could not complete start up.It was noted that the issue occurred while setting up equipment for the procedure.It was reported that the site continued with the procedure without the system.There was no reported delay to the procedure due to this issue.There was no reported impact on patient outcome.Following the procedure, a medtronic representative removed the primary hd of the system and attempted to boot with the archive hd but without resolution.It was noted that the previous time the system was used, it functioned as designed.It was reported that all cables were reported to be secure.No additional information was provided.

Manufacturer Narrative

H3: a medtronic representative went to the site to test the equipment.Testing revealed that the system functioned as designed during a planned maintenance (pm).The system then passed the system checkout and was found to be fully functional.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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: POLESTAR N30 SURGICAL MRI SYSTEM
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): MEDTRONIC NAVIGATION ISRAEL, LTD; 3 hacarmel street p.o. box 548; kochav yokneam building; yokneam elit ha zafon
• MDR Report Key: 7955992
• MDR Text Key: 123393128
• Report Number: 9710108-2018-00001
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K092308
• 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: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9734070
• Device Catalogue Number: 9734070
• Device Lot Number: WO081102440190
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1