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

Device Problems Device Alarm System (1012); Thermal Decomposition of Device (1071); Loss of Power (1475)

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

Event Date 09/23/2019

Event Type  malfunction  

Event Description

Stealth navigation system suddenly shut down.Pt was anesthetized.Rep attempted to troubleshoot without success.Procedure cancelled.Upon review by vendor, machine burned and no faults found.Machine placed back into service.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC STEALTHSTATION S7
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.
• MDR Report Key: 9174614
• MDR Text Key: 161945498
• Report Number: MW5090318
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR