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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. REVEAL LINQ LOOP RECORDER; DETECTOR AND ALARM, ARRHYTHMIA
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MEDTRONIC, INC. REVEAL LINQ LOOP RECORDER; DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number LNQ11
Device Problem Loss of Data (2903)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/14/2017
Event Type  Injury  
Event Description
Medtronic mycarelink patient monitor (model 2450llq, sn # (b)(4)) stopped transmitting data nightly/monthly data from my reveal linq loop recorder (model # lnq11, sn # (b)(4)) to physician's office.Pt had to request a 2nd medtronic mycarelink patient monitor (model # 24950 llq, sn # (b)(4)) which also stopped automatically transmitting nightly/monthly data to physician's office and medtronic.Patient had to request a 3rd medtronic mycarelink patient monitor, and is currently using (model 24950, sn # (b)(4)) which is still working.There is obviously something wrong with the transmitting data over time of either the medtronic reveal linq loop recorder itself or the medtronic mycarelink patient monitors.This is very concerning as a patient and to physicians as it transmits crucial heart rhythm data which is monitored carefully from the physician's office.Fda safety report id # (b)(4).
 
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Brand Name
REVEAL LINQ LOOP RECORDER
Type of Device
DETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
MEDTRONIC, INC.
MDR Report Key8654384
MDR Text Key146678418
Report NumberMW5086977
Device Sequence Number3
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 Patient
Type of Report Initial
Report Date 05/24/2019
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received05/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberLNQ11
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age52 YR
Patient Weight73
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