MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. REVEAL XT; DETECTOR AND ALARM, ARRHYTHMIA

Model Number 9529

Device Problem Under-Sensing (1661)

Patient Problems Chest Pain (1776); Palpitations (2467)

Event Date 06/08/2016

Event Type  malfunction  

Event Description

It was reported that the patient presented with complaint of chest pain and palpitations.The device was suspected of exhibiting intermittent oversensing.The device remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: REVEAL XT
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5862697
• MDR Text Key: 51835378
• Report Number: 3004209178-2016-16360
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2016
• 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: 06/08/2016
• Initial Date FDA Received: 08/09/2016
• Supplement Dates Manufacturer Received: 06/08/2016
• Supplement Dates FDA Received: 09/24/2017
• Date Device Manufactured: 05/16/2015
• 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: 63 YR