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

Model Number S7

Device Problem Imprecision (1307)

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

Event Date 12/14/2016

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2016 a medtronic representative, following-up at the site, reported speaking with the site chief resident who stated that the post-op mri showed that the patient anatomy had shifted from what they were seeing on the navigation system scan they used in the procedure, which was from two weeks before.What the chief resident thinks happened is the anatomy shifted when they were going through the cerebellum.He believes the navigation system was accurate, the post-op scan showed they were where they thought they were.The chief resident stated they would not be performing a second surgery.On (b)(6) 2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.On (b)(6) 2016 software analysis was unable to determine probable cause with the information provided.Anatomy shift is suspected to be the cause of the reported issue.Review of patient exams finds the exams conformed to medtronic imaging protocol and were sufficient for navigation.

Event Description

A medtronic representative received a report from a site, alleging that their navigation system was inaccurate approximately 1-2 centimeters medial and lateral while in a cranial resection procedure.The patient was posterior and tracer registration was utilized.The medtronic representative reported that the site was unable to locate the cavernous malformation and sent the patient to magnetic resonance imaging (mri).The surgeon opted to discontinue the use of the navigation system to continue.The surgeon opted to complete the procedure without the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.

• 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: 6244479
• MDR Text Key: 64578094
• Report Number: 1723170-2017-00087
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• 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

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2013
• 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: 44 YR
• Patient Weight: 98