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 Peripheral Vascular Disease (2002); Transient Ischemic Attack (2109)

Event Date 01/01/2015

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.The gender of the baseline characteristics is male and the baseline age is 59 years old.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.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.Referenced article: predictors of arrhythmic events detected by implantable loop recorders in renal transplant candidates.Arq.Bras.Cardiol.2015;105(5):493-502.(b)(4).

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 was about the "incidence and predictors" of patient who were renal transplant candidates and the use of ilrs.The article stated that there was a report of infection in which the ilr was removed.There were reported nonfatal major cardiovascular events which included acute pulmonary edema (9 patients), acute myocardial infarction (2 patients), acute peripheral vascular disease (2 patients), and ischemic stroke (1 patient).In addition, 14 patients underwent renal transplantation.The status of most of the ilrs is unknown.No 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 CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5423708
• MDR Text Key: 37911133
• Report Number: 2182208-2016-00315
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 12/03/2015
• Initial Date FDA Received: 02/09/2016
• 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; Life Threatening; Required Intervention
• Patient Age: 00059 YR