MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3369-40Q

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

Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994); Swelling (2091); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 10/19/2020

Event Type  Injury  

Manufacturer Narrative

Patient code: 2331 complaint ill-defined - the patient experienced hot to the touch sensation at the device pocket site.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient developed an infection and experienced on and off fever.The patient also reported experiencing swelling, pain, and hot to the touch sensation at the implant pocket of the implantable cardioverter defibrillator.The source and date the infection developed was not determined.However, it was noted that the patient had an atrial lead replacement completed on the (b)(6) 2020.An echocardiogram was completed which revealed there was vegetation on the old atrial lead.On (b)(6) 2020, the entire implantable cardioverter defibrillator system was removed successfully.The patient was reported to be in stable condition.Related manufacturer reference number: 2017865-2020-15935, 2017865-2020-15936, 2017865-2020-15937.

Manufacturer Narrative

The device was tested on the bench, and no anomalies were found.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10715185
• MDR Text Key: 212447612
• Report Number: 2017865-2020-15934
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508377
• UDI-Public: 05414734508377
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: CD3369-40Q
• Device Catalogue Number: CD3369-40Q
• Device Lot Number: A000024886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DURATA; QUARTET; TENDRIL STS
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 76