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

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.

• 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: 7980526
• MDR Text Key: 124509684
• Report Number: 2182208-2018-01898
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K132649
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 10/18/2018
• 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 Age: 63 YR