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

Model Number LNQ11

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Skin Erosion (2075); Discomfort (2330)

Event Date 08/01/2017

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.Patient information is limited due to confidentiality concerns.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: reveal linq versus reveal xt implantable loop recorders: intra- and post-procedural comparison.Journal of pediatrics.2017; 187:290-294.10.1016/j.Jpeds.2017.04.057.

Event Description

A journal article was reviewed which contained information regarding implantable cardiac monitors (icms).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 that patients experienced device erosion, infection at the implant site, and soreness at the implant site.The status of the devices 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: 7178786
• MDR Text Key: 96857926
• Report Number: 2182208-2018-00007
• 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: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• 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
• 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 Age: 13 YR