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

Model Number S7

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 02/06/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative inspected the navigation system onsite and confirmed that there was no signal going to the surgeon monitor.Additionally, the uninterruptible power supply (ups) was not functioning when the system was unplugged.The power supply was replaced and the issue resolved.The representative also replaced the uninterruptible power supply (ups) and ups batteries.A full system check-out was completed following part replacement and all tests passed.Full system functionality was confirmed and the system was returned to service.No parts have returned to the manufacturer for evaluation.

Event Description

A medtronic representative reported that while outside of a procedure, the surgeon monitor on the navigation system was not getting power.The representative tested the output on the multi-out power supply and was not getting any voltage back form the monitor input.There was no patient present when this issue was observed.

Manufacturer Narrative

The uninterruptible power supply (ups) was returned to the manufacturer for evaluation.When attached to a known operational battery, the ups would power down immediately.It was noted that all outputs measure normally once the ac was disconnected.The power supply of the imaging system was returned to the manufacturer for evaluation.Testing found that there was a fuse that was open on the board of the power supply.

• 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 ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7307936
• MDR Text Key: 101348974
• Report Number: 1723170-2018-00962
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2010
• 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