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 04/15/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Concomitant medical products: other relevant device(s) are: product id: 9735796r, lot/serial #: unknown.Initial reporter not known at the time of reporting.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 procedure.It was reported that the pcoip has been intermittently cycling.The site sent the manufacturer representative a pictures and the camera cart monitor goes to searching for network connection, unable to connect, and then the pcoip screen cycles.This happens intermittently during cases.There was no delay to the procedure.No impact on patient outcome.

Manufacturer Narrative

Additional information was received.Device evaluation: system a medtronic representative visited the site to evaluate the equipment.The representative replaced the pcoip.Codes 'method/result/conclusion" are applicable.Device evaluation: concomitant product, the unit was tested and found to be configured properly to 100 mbps but still exhibited power cycling.Logs indicated that there were 2 occurrences within the logs.Method/result/conclusion codes are applicable.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that it is unknown if the issue happened during procedures.Cause is also unknown.There were no delays, as the site used the surgeon monitor while the camera monitor cycled (roughly 30 seconds).The site did not have record of any patients/cases this issue may have occurred in.

• Brand Name: S8 PREMIUM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9972519
• MDR Text Key: 188340696
• Report Number: 1723170-2020-01252
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00763000272739
• UDI-Public: 00763000272739
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1