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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA

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MEDTRONIC EUROPE SARL REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number LNQ11
Device Problems Break (1069); Migration or Expulsion of Device (1395); Under-Sensing (1661)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/06/2020
Event Type  Malfunction  
Manufacturer Narrative

Product event summary: the device was not returned for analysis. However, performance data collected from the device was received and analyzed. Analysis of the device memory was performed and no anomalies were found. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the implantable cardiac monitor (icm) detected false pause episodes which suggested movement of the device. It was further reported the icm showed separation between the header and the can. The icm was explanted. No patient complications have been reported as a result of this event.

 
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Brand NameREVEAL LINQ
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10060509
MDR Text Key191077793
Report Number9614453-2020-01522
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK132649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/25/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/15/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2018
Device MODEL NumberLNQ11
Device Catalogue NumberLNQ11
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/16/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/10/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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