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

Model Number S7

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Patient Involvement (2645)

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Udi and device manufacturing date unavailable.A medtronic representative went to the site to replace the monitor and test the equipment.The imaging system then passed the system checkout and was found to be fully functional.The customer declined to return the part to the manufacturer for evaluation.

Event Description

A site representative reported that the surgeon monitor could not display normally during surgeon training.The display appeared to flash intermittently, and then suddenly the entire screen appeared black.There was no patient present when this issue was identified.

Manufacturer Narrative

Additional information: udi received.Device manufacturing date received.Both fields updated with the correct information.

Manufacturer Narrative

The monitor was returned to the manufacturer for analysis.Analysis found that the issue could not be duplicated.No fault was found with the monitor.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: date new information was received was inadvertently left out of supplemental 002.Date information was received was: 2018-09-25.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: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7343829
• MDR Text Key: 102583926
• Report Number: 1723170-2018-01162
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/24/2018

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 Model Number: S7
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 03/22/2018; 10/24/2018; 10/24/2018
• Supplement Dates FDA Received: 04/03/2018; 10/24/2018; 10/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2017
• 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