MAUDE Adverse Event Report: ON-X ON-X AVR PROSTHETIC HEART VALVE

Device Problem Programming Issue (3014)

Patient Problems Cardiopulmonary Arrest (1765); Dyspnea (1816); Complaint, Ill-Defined (2331); Diaphoresis (2452)

Event Date 05/25/2016

Event Type  Injury  

Event Description

This pt had an outpatient mri with contrast.The pt has a pacemaker and an aortic heart valve.Before the exam, a st.Jude pacemaker rep set the pacemaker to mri mode (asynchronous pulsing) pt was placed on mr safe vitals monitor.Iv contrast was administered roughly 30 minutes into the exam.Pt did not express distress throughout the exam.Upon removing the pt from the scanner, she appeared diaphoretic.The pt sat up, complained of shortness of breath, and presented audible wheezing.Pt was transferred to a stretcher where she deteriorated rapidly, and a code team was called.The code team arrived quickly and began to work the code.Pt was intubated, and stabilized.The st.Jude rep interrogated the pacer and placed it back in normal mode.She was rushed to the emergency room, for further care.This is in conjunction with another voluntary report on a st.Jude pacemaker.

• Brand Name: ON-X AVR PROSTHETIC HEART VALVE
• Type of Device: HEART VALVE
• Manufacturer (Section D): ON-X
• MDR Report Key: 5702755
• MDR Text Key: 46861325
• Report Number: MW5062690
• Device Sequence Number: 1
• Product Code: LWQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 59 YR
• Patient Weight: 113