MAUDE Adverse Event Report: UNKNOWN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D); DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endocarditis (1834); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Peripheral Edema (4578)

Event Type  Injury  

Event Description

It was reported that the patient developed endocarditis.Blood cultures were positive for streptococcus agalactiae.A computerized tomography (ct) angiography revealed thrombus around a pacemaker probe.A transesophageal echocardiography vibratile image was suspicious of endocarditis on one of the probes.The patient was assessed for worsening heart failure and peripheral edema was observed.The patient was hospitalized, and medication was administered.The cardiac resynchronization therapy defibrillator (crt-d) system remains in use.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17488679
• MDR Text Key: 320689618
• Report Number: MW5121379
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2022

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1