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

Model Number S7

Device Problems Thermal Decomposition of Device (1071); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

On 08/05/2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.Return requested.Replacement axiem portable shipped to site 08/04/2016.Medtronic investigation of returned suspect axiem portable finds that when tested on test bench, and after running and getting to operating temperature, amp board c has a temp fault.The axiem fault light comes on and in the software, axiem box is red and shows red status.The axiem is still able to track in this state.Confirmed electrical failure.System fault code.On 08/26/2016 a medtronic representative, following-up at the site, reported the axiem box was not warm to the touch.The issue was identified prior to the start of the procedure while we setting-up the room.The yellow fault lights were on the box and the 'emitter details' tab had the red message, noting: emitter box overheat.No further issues have been reported.

Event Description

A medtronic representative reported that, while in a procedure, the site's navigation system axiem box was overheating, showing red under emitter details, and was unable to track.A second axiem box was brought in to allow the surgeon to proceed.No further details regarding this issue, or specifically when it occurred, were provided.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.There was no patient present when this issue was identified.

Manufacturer Narrative

A medtronic representative, following up with the site, reported that the procedure was a cranial and orbital reconstruction.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 5918423
• MDR Text Key: 53670536
• Report Number: 1723170-2016-03159
• 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,Followup
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2014
• 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: 10 YR
• Patient Weight: 64