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

Model Number 9529

Device Problems Over-Sensing (1438); Under-Sensing (1661)

Patient Problem Sepsis (2067)

Event Date 04/06/2016

Event Type  malfunction  

Manufacturer Narrative

This information is based entirely on journal literature.This event occurred outside the us.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.The gender of the baseline characteristics is male and the baseline age is 68 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:left axillary implantation of loop recorder versus the traditional left chest area: a prospective randomized study.Pace.2016 (39): 830-836.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 cardiac monitors (icm).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 there was one patient death from sepsis, and patients who experienced undersensing and noise.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 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: 7090464
• MDR Text Key: 94519508
• Report Number: 2182208-2017-01888
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem 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
• Date Manufacturer Received: 10/04/2017
• 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: 68 YR