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

Model Number	CD2411-36Q
Medical Device Problem Code	Under-Sensing (1661)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information was requested but was not available at this time.
Event or Problem Description
It was reported that intermittent ventricular undersensing was observed on the implantable cardioverter defibrillator (icd).
Event or Problem Description
New information received notes the patient was asymptomatic, programming changes were made, the patient was to continue with follow up in clinic and was stable before, during and after the event.

• Brand Name: ELLIPSE DR
• 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: 24548360
• Report Number: 2017865-2026-04853
• Device Sequence Number: 12155963
• Product Code: NVZ
• UDI-Device Identifier: 05414734507615
• UDI-Public: (01)05414734507615(10)A000111466(17)230630
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: CD2411-36Q
• Device Catalogue Number: CD2411-36Q
• Device Lot Number: A000111466
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2021
• 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: OPTISURE MRI
• Patient Sex: Female