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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); Invalid Sensing (2293)
Patient Problems Unspecified Infection (1930); Skin Erosion (2075); Discomfort (2330)
Event Date 02/26/2013
Event Type  Injury  
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 product serial numbers. Patient information is limited due to confidentiality concerns. The gender of the baseline characteristics is male and the baseline age is (b)(6) 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: ¿assessing arrhythmia burden after catheter ablation of atrial fibrillation using an implantable loop recorder: the abacus study. ¿ journal of cardiovascular electrophysiology 2013;24:875-881. Doi: 10. 1111/jce. 12141. A good faith effort will be made to obtain the applicable information relevant to the report. 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 (ilr). Multiple patients were noted in the article; however, a one to one correlation could not be made with unique serial numbers with the available information provided. The author reported that there were patients who had false device detections; with the following ¿causes,¿ per the author: noise, t-wave oversensing (twos), and loss of electrode contact and/or poor electrode contact. The device also ¿falsely¿ detected/¿misclassified¿ asystole and ventricular tachycardia (vt) due to under/oversensing. There was also one patient who had skin erosion, and one patient who had pocket infection which required the device to be explanted. One patient requested the removal of the ilr due to ¿local discomfort. ¿ one patient requested removal for ¿cosmetic reasons. ¿ the status/location of the ilr is unknown. Further follow up did not yet yield any additional information. No further patient complications have been reported as a result of this event.

 
Manufacturer Narrative

All information provided is included in this report. No further information is available. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Additional information was obtained through follow up with the author who indicated that there was no further information available.

 
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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 Key6936403
MDR Text Key89085209
Report Number2182208-2017-01792
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/07/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/10/2017
Is This An Adverse Event Report? Yes
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 Received10/19/2017
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

Patient TREATMENT DATA
Date Received: 10/10/2017 Patient Sequence Number: 1
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