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

Model Number S7

Device Problem Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.The instructions for use (ifu) that accompanies the device contains warnings regarding patient reference movement: "warning: do not bump or reposition the patient reference after registration.Movement of the patient reference will result in inaccurate navigation.If the patient reference moves in relation to the patient anatomy at any time after registration, you must re-register.".

Event Description

A site representative reported that after they registered they were inaccurate about 4 mm inferior during a cranial resection procedure.The surgeon attempted to move the reference frame and obtain better accuracy.Surgeon requested the reference frame arm to be loosened and re-position the frame.A medtronic representative advised that this was not a method that was advised or that we could verify.The surgeon checked bony landmarks under the skin and felt that it was "ok" and accuracy was "better than it was." a medtronic representative again advised against it, however the surgeon opted to proceed with the surgery.The delay was reported to be less than one hour.The procedure was completed with the navigation system.There was no reported impact to the outcome of the patient.

Manufacturer Narrative

Information received about patient demographics.A software investigation analysis was initiated to determined the probably cause of the issue through reproducibility.Analysis found that the cause of the event was user error and that the software functioned as designed.A medtronic representative went to the site to test the equipment.Testing revealed that after registration, the reference frame was moved which caused the issue.Otherwise system operated as intended.

• 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: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7156331
• MDR Text Key: 96116253
• Report Number: 1723170-2017-05359
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2017
• 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?: Yes
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2010
• 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 Age: 60 YR
• Patient Weight: 80