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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC REVEAL LINQ

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MEDTRONIC REVEAL LINQ Back to Search Results
Model Number LNQ11
Device Problems Device Displays Incorrect Message (2591); Battery Problem (2885)
Patient Problem No Information (3190)
Event Date 01/02/2016
Event Type  malfunction  
Event Description
Product is a medtronic reveal linq loop recorder. This device should have a projected longevity of 3 years. This patient had the ilr implanted on (b)(6) 2014, and on (b)(6) 2016 it showed it had reached it's recommended replacement indicator. Patient has ilr for unexplained syncope and atrial fibrillation. Upon speaking with medtronic engineering, they have advised it is an error within the component of the battery. When the battery reads the impedance value there is a "glitch" that makes the battery read it at "rrt" when really it is not. Once rrt is reached with an ilr, in 30 days it will show that it is at "eos", end of service. Once the ilr reaches "eos", we no longer have the ability to obtain automatic transmissions from the patient's carelink remote transmitter for transmitting patient activated symptom episodes, af burdens being exceeded of "pauses" greater than 3 seconds. The engineering team has suggested that the ilr will continue to work, but we do not know how to tell when it actually reaches rrt or eos and it will require the patient to send manual remote transmissions which will cause us to lose ekg portion of patient activated symptoms. It will record all dates/times each time the patient activator is used, but will only show us an ekg portion for the four most recent. Diagnosis or reason for use: record the heart's rate and rhythm for unexplained events.
 
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Brand NameREVEAL LINQ
Type of DeviceREVEAL LINQ
Manufacturer (Section D)
MEDTRONIC
minneapolis MN
MDR Report Key5357908
MDR Text Key35658111
Report NumberMW5059148
Device Sequence Number1
Product Code DSI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2016
Is this a Product Problem Report? Yes
Device Operator
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? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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