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

Model Number 9733856

Device Problem Output Problem (3005)

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

Event Date 04/13/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 9660651r, lot/serial #: unknown.No parts have been received by the manufacturer for evaluation.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 catheter placement procedure.It was reported that the site was having issues with emitter, the light was flashing during the procedure.The site stated that the status was flickering on the screen.They were accurate while navigating but it did cause a 15 min delay in the case.Troubleshooting involved the manufacturer representative (rep) being unable to recreate the issue.Technical services had them check the em interface and review the status lights on the controller.The rep did not have instruments on hand for testing.

Manufacturer Narrative

Concomitant medical products: product 9660651r updated to 9660651.Lot number for 9660651 is 0200057036.Additional product 9731203, lot number unknown.A medtronic representative went to the site to test the equipment.Testing revealed that parts were replaced.The system then passed the system checkout and was found to be fully functional.The electromagnetic localization system was returned to the manufacturer for analysis.Analysis found that the reported issue could not be confirmed.No failure was found.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received additional information that the site hooked up the new electromagnetic localization system box and the issue persisted.It was clarified that when the navigation light turned off and the system stopped navigating, the emitter also went silent.

Manufacturer Narrative

H2) additional information was provided regarding the system checkout.It was confirmed by the manufacturer representative that replacing the emitter resolved the issue.The codes previously applied to the system checkout (10, 114, 4307) are still applicable.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

H3, h6: the field generator 9731203 em mobile (0400008429) was returned for analysis.Analysis found that the issue could not be replicated.The returned field generator was connected to a test system for overnight testing and no issues were detected.The field generator, axiem and all tools remained tracking throughout the duration of testing.Evaluation codes that apply to this testing: 10, 213, 67.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: S7
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9967587
• MDR Text Key: 188370719
• Report Number: 1723170-2020-01234
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 91