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

Model Number S7

Device Problems Display or Visual Feedback Problem (1184); Application Program Problem (2880); Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Date 10/12/2021

Event Type  malfunction  

Event Description

Or (operating room): craniotomy for resection of parietal tumor with stealth medtronic neuro navigation.Stealth not able to upload radiology mri image from multiple disc burns, it data ports not working, multiple contacts with radiology, it and stealth troubleshooting, but no solution yet.

• Brand Name: STEALTHSTATION S7
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek cir; louisville CO 80027
• MDR Report Key: 12868496
• MDR Text Key: 281206954
• Report Number: 12868496
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2021,10/19/2021

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 Model Number: S7
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2021
• Date Report to Manufacturer: 11/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1