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 Stroke/CVA (1770); Unspecified Infection (1930); Pain (1994); Transient Ischemic Attack (2109); Discomfort (2330); Blood Loss (2597)

Event Date 01/01/2016

Event Type  Injury  

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.The baseline gender/age of the patients is male/72 years of age.Since no device id was provided, it is unknown if this event has been previously reported.The pma number for this report listed is part of a combination of pmas considered the "1-card" and consists of p820003, p850051, p890003, p930022, p970012 and p980035.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: oral anticoagulation after successful atrial fibrillation ablation operations: is it necessary? annals of thoracic surgery.2016;101(4):1471-1476.A good faith effort will be made to obtain the applicable information relevant to the report.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 (icms).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 were complications such as wound infections, "neurological events [stroke or transient ischemic attack], " bleeding complications," and "other device-related complications." there were reports of patients having their icm removed due to discomfort." the status of the icms is unknown.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Further analysis of the event prompted a change in the conclusion code.

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, 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: 5858596
• MDR Text Key: 51725737
• Report Number: 2182208-2016-01829
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: 1-CARD
• 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,Followup,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this an Adverse Event Report?: Yes
• 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: 06/28/2016
• 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: 72 YR