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

Model Number I7

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Brain Injury (2219); Injury (2348); Iatrogenic Source (2498)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2016 software investigation completed.Findings are that the cranial synergy software is functioning as designed.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's stealthstation i7 integrated navigation system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

Event Description

A medtronic representative reported that while in a transsphenoidal procedure, the surgeon nicked the patient's carotid artery.Reported was that this event was not due to the navigation system.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.The medtronic representative confirmed that the site worked on the carotid and then ended up having to do a craniotomy to deal with a stroke the patient had.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's stealthstation i7 integrated navigation system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

• 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: judith ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6244228
• MDR Text Key: 64577011
• Report Number: 1723170-2017-00094
• 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: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: I7
• Device Catalogue Number: 9734060
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 58