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

Model Number S7

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); No Display/Image (1183)

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

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Device manufacturing date is unavailable.No parts have been received by the manufacturer for evaluation.Part not returned for evaluation.

Event Description

A medtronic representative reported during cranial resection, the navigation system booted up and the study was loaded but before registration the screen of the system was not displaying an image.The system was shut down with the switch on button but after that the system would not boot up.When booted up from the central processing unit (cpu) directly the issue persisted.The procedure was completed without the use of navigation and imaging.There was no delay to procedure.No known impact on patient outcome.

Manufacturer Narrative

Additional information: device manufacture date received.Correction: correct catalog and udi numbers have been added to the appropriate fields.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the system would not boot up.The cmos battery was find however the system does not boot up manually.Replacing the computer resolved the issue.The system then passed the system checkout and was found to be fully functional.The computer has not been received by the manufacturer for evaluation.

Manufacturer Narrative

Analysis on the returned computer resulted in no failure being found through functional testing, visual/physical examination and proceduralized device testing.Analysis states that the initial boot-up of the computer was normal, as no issues were observed.Boot from admin, also good.Navigation of software performed as expected.If information is provided in the future, a supplemental report will be issued.

• 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: prashanth gali ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7426276
• MDR Text Key: 105419861
• Report Number: 1723170-2018-01608
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/04/2018

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: 9733858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 04/17/2018; 09/12/2018; 09/12/2018
• Supplement Dates FDA Received: 05/11/2018; 09/17/2018; 12/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2017
• 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