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

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.

• Brand Name: REVEAL LINQ
• Type of Device: DETECTOR 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 Key: 7253926
• MDR Text Key: 99543395
• Report Number: 2182208-2018-00063
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• 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 Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LNQ11
• Device Catalogue Number: LNQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 86