MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA CRT-D QUAD RF HV; NO MATCH

Model Number CD3365-40Q

Device Problem Pacing Asynchronously (1441)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/27/2023

Event Type  Injury  

Event Description

It was reported that the patient's implantable cardioverter defibrillator (icd) exhibited competitive atrial pacing.The icd was explanted and replaced.The patient's status was unknown.

Manufacturer Narrative

The reported event of competitive atrial pacing was not confirmed.Final analysis found no anomalies.

• Brand Name: QUADRA ASSURA CRT-D QUAD RF HV
• Type of Device: NO MATCH
• 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: 17953410
• MDR Text Key: 326270193
• Report Number: 2017865-2023-49968
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508292
• UDI-Public: 05414734508292
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: CD3365-40Q
• Device Lot Number: A000032184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2016
• 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: QUARTET; SJM ATRIAL LEAD; SJM RIGHT VENTRICULAR LEAD
• Patient Outcome(s): Required Intervention
• Patient Sex: Male