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

Catalog Number 9735665

Device Problems Computer Software Problem (1112); Failure to Obtain Sample (2533)

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

Event Date 08/22/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.No parts have been returned to the manufacturer for analysis.

Event Description

Medtronic received information regarding a navigation device.It was reported that system was displaying the trace pattern on the back of the head.Registration attempted four times without resolution.An alternate navigation system was utilized to complete the procedure.There was no impact to patient.There was a reported delay to the procedure of less than 1 hour due to this issue.

Manufacturer Narrative

Correction: correcting fdad code to proper value.A software analysis was initiated to determine the probable cause of the issue through review of the reported issue.By reviewing the case detail reported all the trace patterns were composed of a large amount of forehead points with very little unique anatomy such as nose.Analysis found that the reported event was related to a software issue.This issue was documented in a medtronic 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: koko tyler ; navigation customer quality; 826 coal creek circle; louisville, CO 80027 ; 7208903200
• MDR Report Key: 7872694
• MDR Text Key: 120153524
• Report Number: 1723170-2018-04626
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2018

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: Health Professional
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/13/2018
• Supplement Dates Manufacturer Received: 09/20/2018
• Supplement Dates FDA Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2017
• 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