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 Fever (1858); Unspecified Infection (1930)

Event Date 01/11/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2021-02364, related manufacturer reference number: 2017865-2021-02365.It was reported that the patient presented to the hospital on (b)(6) 2021 with fever and signs of infection.Upon examination, it was noted that the patient had inflammation from unknown source.Echocardiogram revealed vegetation on right ventricular (rv) lead.The physician explanted the implantable cardioverter defibrillator (icd), the rv lead and right atrial lead on (b)(6) 2022.The patient was in stable condition.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Review of the sterilization records confirmed normal sterilization cycles for the products.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13419894
• MDR Text Key: 284863389
• Report Number: 2017865-2022-02363
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: CD3357-40Q
• Device Catalogue Number: CD3357-40Q
• Device Lot Number: A000069004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White