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

Model Number	CD1411-36C
Medical Device Problem Codes	Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	07/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in-clinic with discomfort as the implantable cardioverter defibrillator (icd) exhibited inappropriate defibrillation therapy due to over-sensing of noise.As a resolution programming changes were made.The patient condition was stable.
Event or Problem Description
Additional information received confirmed that as a resolution the implantable cardioverter defibrillator (icd) was explanted and replaced.The patient condition was unknown.
Additional Manufacturer Narrative
The reported event of inadequate shock stimulation and sensing noise was not confirmed.The device was received at elective-replacement level, with normal output and telemetry communication.Visual inspection, electrical and mechanical tests did not identify any functional issues.

• 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: 22646288
• Report Number: 2017865-2025-96039
• Device Sequence Number: 12925255
• Product Code: NVZ
• UDI-Device Identifier: 05414734507707
• UDI-Public: (01)05414734507707(10)4764051(17)160831
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2025

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: 08/31/2016
• Device Model Number: CD1411-36C
• Device Catalogue Number: CD1411-36C
• Device Lot Number: 4764051
• 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: 07/13/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 09/30/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/07/2025; 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2014
• 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: RV.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male