MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. LEFT THORACIC PROBE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/30/2020

Event Type  malfunction  

Event Description

Navigated medtronic gearshift broke off in patient vertebrae during surgery.After multiple failed attempts to remove the embedded piece of instrument, surgeon consulted medtronic concerning the safety of the materials in the remaining piece.After careful review of the risks/benefits, surgeon decided to leave the piece in the patient.This instrument is manufactured by medtronic, and is instrument kit #9735206 left thoracic probe.The serial numbers are (b)(4) and (b)(4).Fda safety report id# (b)(4).

• Brand Name: LEFT THORACIC PROBE
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.
• MDR Report Key: 10319612
• MDR Text Key: 200654533
• Report Number: MW5095686
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/21/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• 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: 51 YR
• Patient Weight: 108