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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 Failure to Interrogate (1332); Migration or Expulsion of Device (1395)
Patient Problems Chest Pain (1776); Dyspnea (1816); Skin Irritation (2076); Sweating (2444)
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative

This information is based entirely on journal literature. All information provided is included in this report. Patient information is limited due to confidentiality concerns. 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: ¿migration of an implantable loop recorder into the pleural space. ¿ preminger m. W. , musat d. L. , sichrovsky t. , bhatt a. G. , mittal s. Heartrhythm case reports. 2017; 3(11):539-541. Doi: 10. 1016/j. Hrcr. 2017. 07. 012.

 
Event Description

A journal article was reviewed which contained information this model of an implantable loop recorders (ilrs). The article reported that on the 35th day post-procedure to implant the ilr, there was a patient who presented to the emergency room (er) after a ¿sudden onset¿ of chest discomfort, shortness of breath and sweating. A chest radiograph showed that the ilr had ¿migrated into the left pleural space. ¿ the physician was also unable to interrogate the ilr by using the programmer head. The patient was taken to the operating room for surgery to locate and subsequently remove the ilr. It was discovered that there was an area of ¿erythema on the pleural surface in the anterior fourth intercostal space. ¿ the patient had an ¿uneventful¿ recovery. The status 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.

 
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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 Key7253926
MDR Text Key99543395
Report Number2182208-2018-00063
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 HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial
Report Date 02/08/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/08/2018
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 Received12/12/2017
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: 02/08/2018 Patient Sequence Number: 1
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