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U.S. Department of Health and Human Services

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

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MEDTRONIC, INC. MEDTRONIC IMPLANTABLE LOOP RECORDER DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
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).

 
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Brand NameMEDTRONIC IMPLANTABLE LOOP RECORDER
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
MEDTRONIC, INC.
MDR Report Key9616200
MDR Text Key176091787
Report NumberMW5092381
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberLNQ11
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/21/2020 Patient Sequence Number: 1
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