MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 PREMIUM SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9735665

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.It was reported that the hard drive of the navigation system was replaced to restore functionality.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The hard drive was returned to the manufacturer for evaluation.Testing found that the hard drive had multiple occurrences of intermittent start up errors appearing.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

Event Description

A medtronic representative reported that, while outside of a procedure, the navigation system would intermittently not complete startup.It was noted that the restarting the navigation system, with the two carts separated would restore functionality.There was no patient present when this issue was identified.No additional information was provided.

Manufacturer Narrative

Device evaluation: the software investigation found that the reported event was related to a software issue.This issue was documented in a navigation software anomaly tracking database.

• Brand Name: STEALTHSTATION S8 PREMIUM SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7321262
• MDR Text Key: 101971645
• Report Number: 1723170-2018-01042
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

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: Physician
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/07/2018
• Supplement Dates Manufacturer Received: 03/13/2018
• Supplement Dates FDA Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2017
• 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