MAUDE Adverse Event Report: MEDTRONIC MELODY; HEART VALVE

Model Number PB1018

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Endocarditis (1834); Unspecified Infection (1930)

Event Date 03/31/2016

Event Type  Death  

Event Description

Caller reported that her son had a melody heart valve implanted in (b)(6) 2010, and it got infected in 2012 and 2015.The pt died of endocarditis on (b)(6) 2016.

• Brand Name: MELODY
• Type of Device: HEART VALVE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6229118
• MDR Text Key: 64061177
• Report Number: MW5067082
• Device Sequence Number: 1
• Product Code: NPV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: PB1018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 19 YR