MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE VR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	CD1411-36C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Type of Reportable Event	Death
Event or Problem Description
It was reported by the patient's wife that the patient died of a cardiac arrest.The wife was concerned the patient's transmitter allegedly did not alert of a cardiac arrest and that the implantable cardioverter defibrillator (icd) was defective.Information received suggests the patient experienced a fall backwards as he got up on (b)(6) 2025.911 was called and the patient was transported to the emergency room and admitted to the intensive care unit (icu) where he passed away (b)(6) 2025.Information received from the following clinic indicates the patient's last in person follow up with their physician was (b)(6) 2024, and system interrogation was normal.The physician travelled out of town for the visit.The patient was due for a yearly in person visit (b)(6) 2025 but did not present for the appointment.The patient was also being monitored remotely at the facility's remote monitoring clinic.The last remote transmission received and checked by the physician from the remote monitoring clinic was dated (b)(6) 2024.The patient¿s presenting rhythm was ventricular fibrillation with ventricular tachycardia (vf/vt), battery longevity 6.5 yrs, the device/system function was stable per physician notes in (b)(6) 2024, and the next remote transmission follow up was scheduled to be 91 days from this review.No other transmission was received for review.The device remains implanted and will not be returned.The patient was noted to have diabetes as well as other cardiac issues unrelated to the system for which they were receiving treatment from other cardiologists as well as other co-morbidities.The cause of death listed on the death certificate was (1) cardiac arrest (2) encephalopathy.The manner of death is recorded as natural causes.The patient's relative disputes the cause of death.
Additional Manufacturer Narrative
Following physician: dr.(b)(6).Hospital where patient died: (b)(6) medical center, (b)(6).
Additional Manufacturer Narrative
The provided session record from march 4th was reviewed by technical services and it was observed that the device was performing per programmed settings.Session records around the time of patient death were unable to be obtained.The device history record review was performed, and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: ELLIPSE VR
• 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: 22028945
• Report Number: 2017865-2025-53821
• Device Sequence Number: 12827102
• Product Code: NVZ
• UDI-Device Identifier: 05414734507707
• UDI-Public: (01)05414734507707(10)A000108063(17)230331
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: CD1411-36C
• Device Catalogue Number: CD1411-36C
• Device Lot Number: A000108063
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2021
• 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: MED 6935-65 RV LEAD TAU088995V
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Death
• Patient Sex: Male