MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number I7

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Patient Involvement (2645)

Event Date 11/07/2016

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Return requested.Replacement computer shipped to site 11/07/2016.Medtronic investigation of returned suspect computer finds that initial power on and boots to log-in screen normally, no sr manager error seen.Launches cranial application without error and navigates.Hard drive was reporting 86 bad sectors which were able to be repaired with seatools.The navigation system finished and passed testing on phd up thru all hard drive tests and passing.Final analysis not completed, suspect computer remains under analysis.- on 11/07/2016 in trouble-shooting,medtronic representative reported that after uninstalling and reinstalling the cranial software, the sr manager failure message went away, however, the navigation system would become unresponsive every time he attempted to enter the cranial software.- on 11/08/2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.

Event Description

A medtronic representative reported that the navigation system became unresponsive when in the cranial application and when the site re-booted the system and attempted to log back into cranial.The navigation system displayed an sr manager failure error.No further details regarding the behavior, or specifically when it occurred, were provided.There was no patient present when this issue was identified.

• Brand Name: STEALTHSTATION I7 INTEGRATED NAVIGATION 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: 6139684
• MDR Text Key: 61306095
• Report Number: 1723170-2016-05621
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994653482
• UDI-Public: 00613994653482
• 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: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: I7
• Device Catalogue Number: 9734060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2010
• 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