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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Irritation (1941); Skin Discoloration (2074)
Event Date 04/05/2018
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the patient experienced an infection, redness, and irritation at the insertion site of the implantable cardiac monitor (icm); the patient was treated with antibiotics. The icm was replaced. No further patient complications have been reported as a result of this event.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7458855
MDR Text Key106447628
Report Number9614453-2018-01316
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK132649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/25/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/14/2018
Device MODEL NumberLNQ11
Device Catalogue NumberLNQ11
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/16/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/25/2018 Patient Sequence Number: 1
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