MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S7 STAFF ASSEMBLED; INSTRUMENT, STEREOTAXIC

Model Number 9733856

Device Problems Human-Device Interface Problem (2949); Audible Prompt/Feedback Problem (4020)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding a navigation system used outside of a procedure.It was reported that there the monitor was beeping when plugged in and the camera lights were flashing.The site did trouble shooting at the time of the event and there was no position sensor unit (psu) listed it was noted that it was likely disconnected.The sensor control unit (scu) would not produce logs they attempted upgrading setup utility but it was unable to pass first step.There was no patient involved.

Manufacturer Narrative

The sensor control unit was sent out for vendor analysis.The issue was confirmed and isolated to the internal mainboard which was replaced.(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3: onsite functional and visual examination was performed by a manufacturer representative.Hardware parts were replaced and the issue was resolved.The system passed a system checkout and was returned to an operational condition.Codes associated with the system: fdr 114, fdc 4307 h3: the scu was returned to the manufacturer for analysis.Functional testing determined that the returned scu continuously cycled the com tones when connected to a known good psu on the test bench.Was not able to read the event log due to an error and was not able to read the system status.Codes associated with the scu.Fdr 120, fdc 4307 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

New information received: the system¿s cables were found to be working, serial numbers were not recorded.Source of error was determined to be spectra scu (b)(6) which was replaced with s/n (b)(4).Site has been made aware of all components remaining in system as well as units replaced and site representative was present for system checkout.

• Brand Name: S7 STAFF ASSEMBLED
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9659725
• MDR Text Key: 177648656
• Report Number: 1723170-2020-00330
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Device Lot Number: T303969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 02/02/2020; 04/20/2020
• Supplement Dates FDA Received: 02/24/2020; 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1