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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA

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MEDTRONIC, INC. REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number LNQ11
Device Problems Over-Sensing (1438); Under-Sensing (1661)
Patient Problem Skin Erosion (2075)
Event Date 07/24/2017
Event Type  Malfunction  
Manufacturer Narrative

This information is based entirely on journal literature. All information provided is included in this report. Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers. The gender of the baseline characteristics is male and the baseline age is 63 years old. 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. Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: clinical impact, safety, and accuracy of the remotely monitored implantable loop recorder medtronic reveal linq tm. Europace. 2018; 20(6):1050-1057. Doi: 10. 1093/europace/eux187. If information is provided in the future, a supplemental report will be issued.

 
Event Description

A journal article was reviewed which contained information regarding implantable loop recorders (ilrs). Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers. The article reports false bradycardia detection due to undersensing and false tachycardia detection due to oversensing. It was noted that one patient experienced skin erosion requiring explantation of the ilr. The status of each ilr is unknown. 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, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7980526
MDR Text Key124509684
Report Number2182208-2018-01898
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK132649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/18/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/18/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
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 Received09/21/2018
Was Device Evaluated By Manufacturer? No Answer Provided
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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