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

Model Number CD3371-40QC

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

Patient Problem Pericardial Effusion (3271)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are unconfirmed since the device was not returned for analysis.Based on the information received, the cause of the reported incident remains unconfirmed.

Event Description

It was reported that following implant it was noted that the patient reported chest pain at the end of inhalation or during continuous sitting, made worse by laying on their back.A device check was performed and a transthoracic echo performed revealed 3mm of pericardial effusion.The patient was prescribed colchicine to treat the pericardial effusion and was to continue with a monthly follow up.

Event Description

New information notes that the symptoms of chest pain continued after medication stopped, and so medication was prescribed for another 3 months.

Event Description

New information notes that the patient was brought in for a transthoracic echocardiogram on (b)(6) 2021, which confirmed that there was no longer pericardial effusion present.

• 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
• 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: 12264084
• MDR Text Key: 264692558
• Report Number: 2017865-2021-27250
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: CD3371-40QC
• Device Lot Number: A000109468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• 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: OPTISURE; QUARTET; TENDRIL
• Patient Outcome(s): Required Intervention