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

Model Number S7

Device Problems Computer Software Problem (1112); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.A medtronic representative inspected the navigation system onsite and confirmed the reported issue.The system passed hardware testing, but software testing failed due to low memory.The representative deleted the old patient exams stored in the system."define ac-pc" was now displaying the scan.The issue resolved.No parts were replaced or returned to the manufacturer for evaluation.

Event Description

A medtronic representative reported that while in an electrode and probe placement procedure, as the site moved forward to the define ac-pc task, the screen was blue and no orthogonal views were shown.The site tried to build a 3d model, but error message, "not enough memory to build 3d model" appeared.The exam directory was 410gb and 356gb of that was being used.There was a reported delay to the procedure of less than 1 hour due to this issue and no impact on the patient outcome.

Manufacturer Narrative

The computer for the navigation system was returned to the manufacturer for analysis.The device was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

Manufacturer Narrative

Patient information was provided by the site.

• 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: divinemercy bakare ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7224810
• MDR Text Key: 98472886
• Report Number: 1723170-2018-00434
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 01/29/2018
• Supplement Dates Manufacturer Received: 02/20/2018; 09/07/2018
• Supplement Dates FDA Received: 02/26/2018; 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2011
• 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: 76 YR
• Patient Weight: 107