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); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented with inappropriate shock noted on the patient's implantable cardioverter defibrillator.No information regarding intervention or adverse patient consequences were reported.

• 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: 22906933
• Report Number: 2017865-2025-98776
• Device Sequence Number: 8018541
• Product Code: NVZ
• UDI-Device Identifier: 05414734507585
• UDI-Public: (01)05414734507585(10)A000137612(17)250131
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2025

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: 01/31/2025
• Device Model Number: CD2411-36C
• Device Catalogue Number: CD2411-36C
• Device Lot Number: A000137612
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 09/04/2025; 09/08/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/04/2025; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RIATA.; RIGHT ATRIAL LEAD.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR
• Patient Sex: Male