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

Model Number 1456Q

Patient Problems Sepsis (2067); Urinary Tract Infection (2120); Cardiogenic Shock (2262)

Event Type  Death  

Event Description

It was reported that the patient with this left ventricular (lv) lead presented to the emergency department (ed) with signs and symptoms of sepsis.The patient was subsequently discharged home to an assisted living facility with antibiotics.The patient subsequently presented to the ed again 17 days later with signs and symptoms of sepsis.The patient was admitted to the hospital and given antibiotics to treat cardiogenic shock due to sepsis but passed away two days later.It was noted in the patient's medical documentation that they had a urinary tract infection, but the cause of the sepsis was not mentioned.The crt-p system was not explanted post-mortem.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17413180
• MDR Text Key: 320055963
• Report Number: MW5120229
• 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: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1456Q
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Death