MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Positioning Problem (3009)

Patient Problems Iatrogenic Source (2498); No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2012

Event Type  Injury  

Event Description

A medtronic representative reported that, while in a cranial biopsy procedure to extract a biopsy from a lesion located in the lower occipital, the surgeon was unable to get trajectory given the location of the burr hole.The lesion was deemed too close to the sinus and the surgeon did not want to proceed with surgery.The surgeon planned the trajectory but only wanted to place the navigus base in a certain area, which restricted the range of needle, additionally, the lesion was 1.3 cm.When the surgeon started navigating to the lesion, determined being too close to the sinus and did not hit the lesion.At that point, the surgeon discontinued navigation and stopped the procedure.Patient is not going to have surgery re-scheduled.The surgeon made no allegation of the navigation system malfunctioning.The medtronic representative and the surgeon discussed the procedure and concerns during planning and the surgeon opted to attempt the surgery with knowledge of the risks.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 s7 system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

Manufacturer Narrative

Patient weight not made available from the site.This event is being reported as a result of a retrospective review of similarly reported events that were initially deemed not-reportable to the fda.The aware date of the need to perform this retrospective review is correctly documented as (b)(4) 2013.Software investigation completed; findings are that the lesion was too close to the sinus and the surgeon did not want to proceed with the case.Unable to get trajectory given the location of the burr hole.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 s7 system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer Contact: judi ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 3555786
• MDR Text Key: 4101207
• Report Number: 1723170-2014-00009
• Device Sequence Number: 1
• Product Code: HAW
• 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: User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2010
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR