MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC IMPLANTABLE LOOP RECORDER; DETECTOR AND ALARM, ARRHYTHMIA

Model Number LNQ11

Device Problems Overheating of Device (1437); Radiation Output Problem (4026)

Patient Problems Erythema (1840); Pain (1994); Burn, Thermal (2530)

Event Date 01/07/2020

Event Type  Injury  

Event Description

Pt's implanted loop recorded heated up during brain mr scan causing a chest burn to the pt.Only visible signs of burn to pt on skin was erythema.Pt also reports deep pain from burn.Fda safety report id#.(b)(4).

• Brand Name: MEDTRONIC IMPLANTABLE LOOP RECORDER
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 9616200
• MDR Text Key: 176091787
• Report Number: MW5092381
• Device Sequence Number: 1
• Product Code: DSI
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: LNQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2020
• 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 Outcome(s): Other
• Patient Age: 34 YR