MAUDE Adverse Event Report: ST. JUDE MEDICAL/ABBOTT MEDICAL DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number 1458Q

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Endocarditis (1834); Unspecified Infection (1930); Septic Shock (2068); Respiratory Failure (2484)

Event Type  Injury  

Event Description

It was reported that the patient with this left ventricular (lv) lead experienced infection.Reportedly, the patient had endocarditis with vegetation identified on the lead and the patient had been in respiratory failure and septic shock.A revision was performed and the crt-d along with the right ventricular (rv) lead, right atrial (ra) lead and this left ventricular (lv) lead were explanted.No additional adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): ST. JUDE MEDICAL/ABBOTT MEDICAL
• MDR Report Key: 17360710
• MDR Text Key: 319537644
• Report Number: MW5119673
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1458Q
• Device Lot Number: BPN021168
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: LEFT VENTRICULAR LEAD.; RIGHT ATRIAL LEAD.; RIGHT VENTRICULAR LEAD.