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

Catalog Number 9735665

Device Problems Erratic or Intermittent Display (1182); Intermittent Communication Failure (4038)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

A system checkout was not required as resolution of the issue was confirmed at the time of the event.No parts have been returned to the manufacturer for evaluation.Part not returned.

Event Description

Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.The issue occurred intraoperatively during the navigate task and delayed the surgery by less than one hour.It was reported that the camera cart monitor went dark and indicated no connection.The monitor cycled power and returned to normal display after 10 seconds.The surgery was completed with navigation and there was no impact on patient outcome.

• 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: tiberious mose ; navigation customer quality; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 7676085
• MDR Text Key: 113623390
• Report Number: 1723170-2018-03288
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• Combination Product (y/n): N
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9735665
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2018
• 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: 76 YR
• Patient Weight: 91