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

Model Number S7

Device Problem Difficult To Position (1467)

Patient Problem Coagulation Disorder (1779)

Event Date 01/03/2016

Event Type  malfunction  

Manufacturer Narrative

The medtronic representative explained that the navigation system is not a live feed and is based on magnetic resonance imaging (mr) / computed tomography (ct) taken before the operation, therefore, clinically it is unknown when the abscess is punctured or not.Even though the software stated that they are in the abscess, the density of the abscess was unknown and was moved by the needle instead of puncturing it.Resolution confirmed on call.A medtronic representative, following-up at the site, reported the surgeon alleged that the biopsy needle may have slid underneath the abscess and that is possibly why they were unable to drain the abscess during surgery.Accuracy confirmed during surgery by touching anatomical landmarks.01/14/2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.01/14/2016 software investigation completed.Findings are that the needle went around the abscess.Software is functioning as designed.No parts have been received by manufacturer for analysis.No further issues have been reported.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.

Event Description

A medtronic representative reported that, while in a cranial biopsy procedure on (b)(6) 2016 to target an abscess, the abscess was never drained.The surgeon was navigating the biopsy needle and when the software stated that they were in the middle of the abscess, the surgeon not able to drain it because they were not puncturing the abscess.The surgeon opted to discontinue the use of the navigation system and abandoned the surgery due to the patient having poor coagulopathy.Post-op computed tomography (ct) on (b)(6) 2016 showed that the needle went around the abscess rather than going inside the abscess.There was no delay.There was no impact on patient outcome.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. (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: 5405523
• MDR Text Key: 37728259
• Report Number: 1723170-2016-00149
• 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: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2012
• 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: 57 YR
• Patient Weight: 91