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 Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient presented remotely via merlin.Net.Review of transmission revealed that non-sustained right ventricular oversensing (nsrvo) due to far p wave over-sensing.Programming changes were suggested but no intervention was performed.Patient condition was stable.
Additional Manufacturer Narrative
The reported events of far p oversensing was not confirmed.The device voltage was at elective replacement indicator (eri) upon receipt.Analysis of device image was performed, and no anomalies were noted.A longevity calculation was performed and found the battery depletion was normal based on the device usage.Electrical testing was performed, and no anomalies were noted.
Event or Problem Description
New information noted that an icd was explanted and replaced with new icd.
Additional Manufacturer Narrative
Correction: "device evaluation" box should also be selected for h2.

• 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: 23379125
• Report Number: 2017865-2025-1003335
• Device Sequence Number: 8824510
• Product Code: NIK
• UDI-Device Identifier: 05414734508292
• UDI-Public: (01)05414734508292(10)A000019874(17)180331
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: CD3365-40Q
• Device Catalogue Number: CD3365-40Q
• Device Lot Number: A000019874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 01/28/2026; 02/23/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 02/18/2026; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OPTISURE.; QUARTET.; TENDRIL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 73 KG