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 Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Onsite functional and visual examination was performed by a manufacturer representative.The computer, and vga splitter were replaced was replaced and the issue was resolved.The system passed a system checkout and was returned to an operational condition.

Event Description

Medtronic received information regarding a navigation device being used for a catheter-based procedure.It was reported that the screen went fuzzy and the system shut down three times during planning.A manufacturer representative tried to replicate the issue on the phone with the site, but the system booted and loaded images fine twice.Use of the navigation and imaging systems was aborted.The procedure was completed and there was no reported impact to the patient.Surgical time was extended by less than one hour.

Manufacturer Narrative

The video splitter was returned to the manufacturer for analysis.Analysis found that the video splitter displayed a good image for each output.No problem was found.The computer was returned to the manufacturer for analysis.Analysis could not replicate the reported issue; no fuzzy screens or automatic shutdowns were observed during testing.However, analysis found that the computer froze while starting the ent application.The software was running slow in the select procedure screen.(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: parker desautel ; navigation customer quality; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 7872832
• MDR Text Key: 120154988
• Report Number: 1723170-2018-04627
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450968
• UDI-Public: 00613994450968
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• 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: 10/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2013
• 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