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

Model Number LNQ11

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Pocket Erosion (2013); Discomfort (2330)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.The overall baseline gender characteristics is male; the age of the patients was approximately 62 years old.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.The model listed in the report is a representative of the model family, as there is no specific model listed.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: "implantable cardiac monitors to detect atrial fibrillation after cryptogenic stroke: a systematic review and economic evaluation." health technology assessment.2020.24(5): v-184.Doi: 10.3310/hta24050.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 cardiac monitors (icm) to detect atrial fibrillation (af) after cryptogenic stroke.Multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.The article reports patients implanted with icms that experienced pain, skin reactions, infection, and pocket erosion which led to device removal.The status/ disposition of the devices is unknown.No further patient complications have been reported as a result of this event.Further follow up did not yet yield any additional information.

• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10905935
• MDR Text Key: 218514194
• Report Number: 2182208-2020-02989
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Physician
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 11/10/2020
• 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): Required Intervention
• Patient Age: 62 YR