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

Model Number 9529

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994)

Event Date 12/18/2018

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.This event occurred outside the us.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.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: extended cardiac monitoring in patients with severe sleep apnea and no history of atrial fibrillation (the reveal xt-sa study).The american journal of cardiology.2018;122 (11): 1885-1889.10.1016/j.Amjcard.2018.08.032.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding an implantable loop recorder (ilr).The article discussed a study that was performed to identify atrial fibrillation (af) in patients with severe sleep apnea.In the study, one patient developed a minor pocket infection and the ilr was re-implanted, another patient experienced a silicon allergy, and one patient had pain.The ilrs were removed from the patients upon reaching two criteria; af with a duration of equal to or greater than ten seconds or when the battery was exhausted (three years).The disposition of the ilrs is not known.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 XT
• 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: 8200611
• MDR Text Key: 131535332
• Report Number: 2182208-2018-02337
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K103764
• 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: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9529
• Device Catalogue Number: 9529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/21/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 57 YR