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

Catalog Number 9735665

Device Problems Device Difficult to Setup or Prepare (1487); Application Program Problem (2880)

Patient Problem No Patient Involvement (2645)

Event Date 06/18/2018

Event Type  malfunction  

Manufacturer Narrative

A system checkout was not required as resolution of the issue was confirmed at the time of the event.No parts have been returned to the manufacturer for evaluation.Device manufacturing date is unavailable at the time of filing.

Event Description

Medtronic received information regarding a navigation device being used for a cranial resection procedure.The issue occurred intraoperatively during the register task and caused no delay to the surgery.It was reported that the site had difficulty registering during case.The tracer points showed below the surface o the 3d model.The surgeon got a sufficient error metric but continued to trace and then the error metric went to a --mm.The surgery was completed with navigation and there was no impact on patient outcome.

Manufacturer Narrative

Additional information: device manufacture date provided.

Manufacturer Narrative

The software investigation found that they were unable to determine the cause of the reported issue.The logs and archives for the navigation system were reviewed by software engineers.However, they were unable to determine the root cause of the issue.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a cranial resection procedure.The issue occurred intraoperatively during the register task and caused no delay to the surgery.It was reported that the site had difficulty registering during case.The tracer points showed below the surface o the 3d model.The surgeon got a sufficient error metric but continued to trace and then the error metric went to a --mm.The surgery was completed with navigation and there was no impact on patient outcome.

• 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7683086
• MDR Text Key: 113876308
• Report Number: 1723170-2018-03381
• 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,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2017
• 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
• Patient Age: 50 YR
• Patient Weight: 73