MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) ELLIPSE DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	CD2411-36Q
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438)
Health Effect - Clinical Code	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 noise was observed on the implantable cardioverter defibrillator (icd).
Additional Manufacturer Narrative
Correction: section e - facility information corrected, physician name unknown.
Event or Problem Description
New information received notes the issue was observed via remote monitoring.The patient was asymptomatic.The noise resulted in oversensing.No changes were made.The patient was stable.

• Brand Name: ELLIPSE DR
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24972166
• Report Number: 2017865-2026-08438
• Device Sequence Number: 21446625
• Product Code: NVZ
• UDI-Device Identifier: 05414734507615
• UDI-Public: (01)05414734507615(10)A000102652(17)221031
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: 10/31/2022
• Device Model Number: CD2411-36Q
• Device Catalogue Number: CD2411-36Q
• Device Lot Number: A000102652
• 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: 04/05/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2020
• 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: DURATA; OPTISENSE
• Patient Sex: Male