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

Model Number S7

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.A medtronic representative went to the site to check the equipment.The reported event could not be duplicated by medtronic personnel.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information that, during posterior cervical spine fusion, the monitor to the navigation system was turning off after 5 minutes.The site tried to disconnect and reconnect the monitor's lemo cable and it would work for another 5 minutes but would shut off again.The site connected another monitor and proceeded with the case.The procedure was completed with the use of navigation.There was no known impact on patient outcome.No delay was reported.The navigation system was used in a case the following day without any issues.A medtronic representative was unable to replicate the reported issue.

• 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: heather davis ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7487213
• MDR Text Key: 107377383
• Report Number: 1723170-2018-01885
• 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,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2018

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?: Yes
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2012
• 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