MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA CRT-D RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3357-40Q

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

Patient Problems High Blood Pressure/ Hypertension (1908); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/02/2023

Event Type  Death  

Event Description

Related manufacturer reference number: 2017865-2023-04606, related manufacturer reference number: 2017865-2023-04607.It was reported that the patient expired on (b)(6) 2023.There is no known allegation from a health care professional that suggests that the death was device related.The cause of death was congestive heart failure and hypertension.

Manufacturer Narrative

Interrogation of the device revealed it was above elective replacement indicator (eri) when received.The device¿s sensing, pacing, lead impedance, high voltage charging, and high voltage shock impedance were tested, and the device¿s function was normal.

• Brand Name: UNIFY ASSURA CRT-D RF HV
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16272896
• MDR Text Key: 308485425
• Report Number: 2017865-2023-04605
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508216
• UDI-Public: 05414734508216
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: CD3357-40Q
• Device Catalogue Number: CD3357-40Q
• Device Lot Number: A000049684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EPICARDIAL LEAD
• Patient Outcome(s): Death
• Patient Age: 84 YR
• Patient Sex: Male