MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE DR ICD; Pulse generator, permanent, implantable

Model Number	CD2411-36C
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Under-Sensing (1661)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented remotely.Remote transmission showed that the patient's implantable cardioverter defibrillator (icd) failed to deliver shock due to undersensing, causing the patient to have ventricular fibrillation.Programming changes were made.The patient had no consequences.

• Brand Name: ELLIPSE DR ICD
• Common Device Name: Pulse generator, permanent, implantable
• 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: 23391082
• Report Number: 2017865-2025-1003451
• Device Sequence Number: 15962160
• Product Code: NVZ
• UDI-Device Identifier: 05414734507585
• UDI-Public: (01)05414734507585(10)A000128503(17)240731
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

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: 07/31/2024
• Device Model Number: CD2411-36C
• Device Catalogue Number: CD2411-36C
• Device Lot Number: A000128503
• 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: 10/10/2025
• Initial Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2022
• 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: RIGHT ATRIAL LEAD; RIGHT VENTRICULAR LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male