MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. PATIENT TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 02/18/2019

Event Type  malfunction  

Event Description

Patient was scheduled for brain surgery under anesthesia.This type of surgery calls for an mr condition 'tracker device' to be stapled to the patient's head for surgery planning.When the patient is ready to have their mri, the tracker wire is coiled up and placed within the proximity of the tracker device per protocol.When the surgery was over, the tracker device was removed by the surgeon and he noticed that there was a burn under the device.The burn size looked to be the diameter of a nickel.I heard the surgeon say that they would have the wound team look at her head.At this time the patient was wheeled out of the room and up to recovery.

• Brand Name: PATIENT TRACKER
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek cir.; louisville CO 80027
• MDR Report Key: 8477497
• MDR Text Key: 140737390
• Report Number: 8477497
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24455 DA