MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number I7

Device Problems Computer Software Problem (1112); Device Stops Intermittently (1599)

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

Event Date 11/03/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.A medtronic representative inspected the navigation system on-site and a software investigation was completed.On-site, the reported issue could not be replicated.The software investigation was similarly inconclusive.Probable cause could not be determined after review of system logs.A full navigation system check-out was completed and all tests passed.Full system functionality was confirmed and the system was returned to service.

Event Description

A site representative reported that during a cranial resection procedure, the navigation system shut down unexpectedly and would not power back on.Details on how the procedure was completed were not provided.The procedure was, however reportedly completed successfully, and there was no impact on the patient.

• Brand Name: STEALTHSTATION I7 INTEGRATED NAVIGATION 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: nicholas mcnabb ; 826 coal creek circle; louisville, CO 80027 ; 7208902439
• MDR Report Key: 6139691
• MDR Text Key: 61311258
• Report Number: 1723170-2016-05584
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994653482
• UDI-Public: 00613994653482
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: I7
• Device Catalogue Number: 9734060
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2010
• 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