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

Model Number S7

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2017

Event Type  malfunction  

Manufacturer Narrative

During the onsite inspection, the medtronic representative reported that the issue was being caused by a faulty computer.The faulty computer was replaced.A successful system checkout was performed which verified that the issue had been resolved.The faulty computer's analysis has not yet been reported.

Event Description

A medtronic representative reported that during cranial biopsy, both monitors started blinking and the system restarted.This was in the navigate task.Delay in surgery was 3 minutes and the site was able to continue the surgery without issue after this.No patient impact was reported.

Manufacturer Narrative

Correction: device manufacture date updated to proper value.The analysis on the suspect computer for the navigation system was completed by medtronic personnel.The computer was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

• 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: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902447
• MDR Report Key: 6606040
• MDR Text Key: 76509336
• Report Number: 1723170-2017-02263
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2012
• 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: 5 YR
• Patient Weight: 16