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

Model Number	CD1411-36Q
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced tachycardia and presented remotely via merlin.Net.Review of transmission revealed that the right ventricular (rv) lead exhibited low, out of range defibrillation impedance and no high voltage output.The rv lead was explanted and replaced on (b)(6) 2025.Additionally, the implantable cardioverter defibrillator (icd) was also explanted and replaced for unspecified reason.The patient was in stable condition.
Additional Manufacturer Narrative
The device was returned for evaluation.The device voltage was above elective replacement indicator (eri) upon receipt.Final analysis did not find any anomalies.

• 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: 23995217
• Report Number: 2017865-2026-00491
• Device Sequence Number: 10185146
• Product Code: NVZ
• UDI-Device Identifier: 05414734507738
• UDI-Public: (01)05414734507738(10)A000088667(17)210831
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 04/15/2026

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: 08/31/2021
• Device Model Number: CD1411-36Q
• Device Catalogue Number: CD1411-36Q
• Device Lot Number: A000088667
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 03/23/2026; 04/03/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/23/2026; 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male