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

Model Number S7

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2016

Event Type  malfunction  

Manufacturer Narrative

Return requested.Replacement axiem portable shipped to site 11/10/2016.No parts have been received by manufacturer for analysis.On 11/11/2016 a medtronic representative performed a navigation system check-out, software and instruments areas passed.Hardware test failed.Axiem communicator not picking up instruments in the field despite having "green" status, replaced axiem communicator.Issue resolved.System performed as intended.

Event Description

A medtronic representative reported that, while in a cranial shunt procedure, the surgeon experienced difficulty tracking the non-invasive patient tracker.They successfully registered the patient and tracked the registration probe, however, when they went to navigate the non-invasive patient tracker (nipt) went to red status.The axiem box and emitter were both showing in green status in the tracking details.Trouble-shooting did not resolve the issue.An alternate navigation system was brought in to be used to continue the procedure to completion.Delay in therapy was less than one hour.There was no impact on patient outcome.

Manufacturer Narrative

The axiem box was returned to the manufacturer for analysis.The device tracked properly with no failures.Visual inspection did find physical damage to the usb connector connecting to the computer, however this did not affect function.The device was found to be fully functional.The reported event could not be duplicated by medtronic personnel.The separate issue found, regarding physical damage, 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6150024
• MDR Text Key: 61615989
• Report Number: 1723170-2016-05668
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• 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: 12/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2009
• 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: 59 YR
• Patient Weight: 75