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

Catalog Number 9735665

Device Problems Device Stops Intermittently (1599); Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.It was reported that the camera communication cable was replaced.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The cable was returned to the manufacturer for evaluation.Testing found that the cable had an intermittent open on one pin within the connector.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

Event Description

A medtronic representative reported that, while outside of a procedure, the camera of the navigation system was not communicating with the main system.There was no patient present when this issue was identified.No additional information was provided.

• Brand Name: STEALTHSTATION S8 BASIC 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
• MDR Report Key: 7299330
• MDR Text Key: 101167187
• Report Number: 1723170-2018-00876
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722194
• UDI-Public: 00643169722194
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9735665
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2017
• 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