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

Model Number CD3357-40C

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 03/28/2023

Event Type  Injury  

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.The product was not returned for additional evaluation and the cause of infection could not be determined.

Event Description

Related manufacturer reference number: 2017865-2023-18457, related manufacturer reference number: 2017865-2023-18458, related manufacturer reference number: 2017865-2023-18459.It was reported that the patient presented in the emergency room due to sepsis.It was noted that there was presence of pus drainage coming from the implantable cardioverter defibrillator (icd) wound incision and wound dehiscence was observed which exposed the icd, right ventricular (rv) lead, right atrial (ra) lead and left ventricular (lv) lead.Pocket revision was performed on 18 apr 2023 due to infection and wound dehiscence.The patient's condition was stable.

Event Description

New information received notes that the patient presented to the emergency room again due to the presence of pus coming from the implantable cardioverter defibrillator (icd) wound incision site and wound dehiscence was observed which exposed the icd, right ventricular (rv) lead, right atrial (ra) lead and left ventricular (lv) lead.The entire icd system was explanted on (b)(6) 2023 due to recurrence infection and wound dehiscence.The patient's condition was stable.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspection 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.The product was returned.Interrogation and visual inspection were normal.Analysis found that the device was received with battery voltage above elective replacement indicator (eri) level.The cause of infection could not be traced to the device.

• 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: 16813186
• MDR Text Key: 313986468
• Report Number: 2017865-2023-18456
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508186
• UDI-Public: 05414734508186
• 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,Followup,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CD3357-40C
• Device Catalogue Number: CD3357-40C
• Device Lot Number: A000131852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2022
• 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: PACING LEAD.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 90 KG