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

Model Number S7

Device Problems Communication or Transmission Problem (2896); Data Problem (3196)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding a navigation system.It was reported outside of a procedure that a scan did not load.The site stated that they were able to load the scan on a different navigation system with 2.2.7 software.There was no patient present at the time this issue was observed.

Manufacturer Narrative

Additional information: medtronic received information that the site was unable to update parameters for loading the exams.Correction: a medtronic representative went to the site to test the equipment.Testing revealed that the reported issue could not be replicated.The system then passed the system checkout and was found to be fully functional.

Manufacturer Narrative

Additional information: it was reported that the issue was with the hospital network.Initial reporter provided.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: a software investigation analysis was initiated to determine the probable cause of the issue through archive/image analysis.Analysis found that the software functioned as designed.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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7817986
• MDR Text Key: 118283557
• Report Number: 1723170-2018-04245
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2016
• 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