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

Model Number	CD3365-40Q
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented in clinic, the patient had experienced discomfort and stimulation.It was noted that the implantable cardioverter defibrillator (icd) was experiencing back up vvi with no backup defibrillation therapy observed due to a magnetic resonance imaging (mri) procedure that had been performed without a mode change.The issue was resolved by performing a device download.The patient was stable.

• Brand Name: QUADRA ASSURA CRT-D QUAD RF HV
• Common Device Name: 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 22286215
• Report Number: 2017865-2025-87640
• Device Sequence Number: 18259654
• Product Code: NIK
• UDI-Device Identifier: 05414734508292
• UDI-Public: (01)05414734508292(10)A000139995(17)250331
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: CD3365-40Q
• Device Catalogue Number: CD3365-40Q
• Device Lot Number: A000139995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown