MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problems Intermittent Loss of Power (4016); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information that, while outside of a procedure, the monitor of the navigation system would intermittently not complete start up.It was noted that the touch screen was unresponsive to prompts from the user when the monitor would start up.An audible beep was noted as well.There was no patient present when this issue was identified.No additional information was provided.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that replacing monitor resolved the issue.The system then passed the system checkout and was found to be fully functional.The monitor has not been received by the manufacturer for evaluation.

Manufacturer Narrative

The surgeon monitor was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was not confirmed.The returned monitor displayed a good image with no anomalies when connected to a known good system.The touch function was found to be normal as well.No problem found.(b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S7 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: prashanth gali ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7677620
• MDR Text Key: 113751791
• Report Number: 1723170-2018-03306
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450968
• UDI-Public: 00613994450968
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2019

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 Model Number: S7
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2018
• Initial Date FDA Received: 07/11/2018
• Supplement Dates Manufacturer Received: 07/17/2018; 07/29/2019
• Supplement Dates FDA Received: 08/14/2018; 08/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2012
• 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