MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S8 PREMIUM; INSTRUMENT, STEREOTAXIC

Model Number 9735665

Device Problems Environmental Compatibility Problem (2929); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation has not been done at the time of submitting this report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used during a sacroiliac and thoracolumbar procedure.It was reported that the system was taking screen shots without anyone touching the system.The system then powered off unexpectedly.The site powered the system back on and the system functioned as intended with no other issues.The clinical specialist (cs) tried to recreate the issue outside of the surgery but was unable to.There was a procedure delay of less than one hour and no impact to the patient.It was reported that the system powering off could have been a result of someone inadvertently stepping on the power cord and it pulling from the wall socket but no one could confirm that.It was confirmed that the system was plugged into a known good outlet.Other items were also plugged into the same outlet with no issues.

• 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: 9865623
• MDR Text Key: 184469658
• Report Number: 1723170-2020-01011
• 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: Physician
• Type of Report: Initial
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• 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: 03/02/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2019
• 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
• Patient Age: 70 YR
• Patient Weight: 82