MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MELODY VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Device Problems Product Quality Problem (1506); Unintended Movement (3026)

Patient Problems Endocarditis (1834); Failure of Implant (1924); Pulmonary Regurgitation (2023)

Event Date 04/08/2019

Event Type  Injury  

Event Description

Melody heart valve caused acute endocarditis.Mfr misrepresents the high rate this valve causes verses bovine / pig valves.More importantly, valve prevents antibiotics from eliminating bacteria in valve.Multiple false readings while valve was infected with staph aureus.Almost killed my son.Had to have open heart surgery to remove melody valve.If i hadn't demanded a pet scan (which showed infected valve leaking into lungs), would have been sent home with ticking time bomb of infected valve in heart.Replaced contaminated melody valve with cow valve.Fda safety report id # (b)(4).

• Brand Name: MELODY VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION
• MDR Report Key: 8777055
• MDR Text Key: 150809886
• Report Number: MW5087997
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 14 YR
• Patient Weight: 58