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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 Problem Skin Erosion (2075)
Event Date 06/01/2021
Event Type  Injury  
Manufacturer Narrative

This information is based entirely on journal literature. Medtronic was made aware of this event through a search of literature publications. This event occurred outside the us. Patient information is limited due to confidentiality concerns. The event only occurred with one patient but specific details on the patient were not provided. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: effect of implantable vs prolonged external electrocardiographic monitoring on atrial fibrillation detection in patients with ischemic stroke the per diem randomized clinical trial. The journal of the american medical association. 2021;325(21 ):2160-2168. Doi:10. 1001/jama. 2021. 6128. If information is provided in the future, a supplemental report will be issued.

 
Event Description

A journal article was reviewed that contained information regarding implantable loop recorders. The article reports one patient who experienced skin erosion with their implantable cardiac monitor (icm) which required a device explant. The status/disposition of the device is unknown. No further 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 MN 1131
SZ 1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud MN 1131
SZ 1131
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key12036743
MDR Text Key257377101
Report Number2182208-2021-02517
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK132649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/29/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/21/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/28/2016
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 Received06/28/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/10/2015
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: 06/21/2021 Patient Sequence Number: 1
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