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

Model Number 9735665

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

No parts have been received by the manufacturer for evaluation.Resolved at the time of issue.

Event Description

A site representative reported that during cranial resection procedure, while navigating a low performance message was displayed on the navigation system.No images were merged.A medtronic representative instructed site to exit the procedure and resume patient which resolved the issue.The procedure was completed with the use of navigation.There was a delay of 5 minutes.No impact on patient outcome.

Manufacturer Narrative

The logs for the navigation system were reviewed by medtronic personnel.It was reported that the logs contained a period greater than the minimal threshold for the reported issue.However, the logs provided no additional insight into the probable cause of the anomaly.

Manufacturer Narrative

Another software analysis was initiated to determine the probable cause of the issue through log analysis.Analysis found that the reported event was related to a software issue.If information is provided in the future, a supplemental report will be issued.

• 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 ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7117999
• MDR Text Key: 94940322
• Report Number: 1723170-2017-05157
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2017
• 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: 66 YR
• Patient Weight: 89