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 05/11/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging system being used for a cranial resection procedure.During image acquisition, an error was received ("ereport: acquisition error: select another protocol").The issue resulted in less than one hour procedure delay.The procedure was completed without the use of imaging.There was no impact on patient outcome.The imaging system was reported as down.No further information was provided.

Manufacturer Narrative

H2) additional information was added to the event description.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 stating that further action was taken and additional logfiles were obtained on (b)(6) 2020.The system event logs were analyzed and the cas communicated with the site.The acquisition error was triggered by an excessive number of external noise (spikes), that was not eliminated by the operator.The current scan was aborted, but the operator ran additional scans in which the issue didn't occur.The error did not prevent image acquisition.

• 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: 10057404
• MDR Text Key: 201684045
• Report Number: 9710108-2020-00001
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1