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

Model Number CD3357-40Q

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

Patient Problems Death (1802); Myocardial Infarction (1969); Loss of consciousness (2418)

Event Date 10/26/2016

Event Type  Death  

Event Description

My father had a heart attack (b)(6) 2016, 911 was called, never regained consciousness and was taken off life support (b)(6) 2016.Defibrillator never went off until he was in the emergency, which was at least 15 mins after 911 was called.Fda safety report id# (b)(4).

• Brand Name: IMPLANTABLE DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER WITH CARDIAC RESYNCHRONIZATION
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 8771689
• MDR Text Key: 150532177
• Report Number: MW5087934
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CD3357-40Q
• Device Catalogue Number: CD3357-40Q
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 91