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

Model Number	CD2411-36C
Medical Device Problem Codes	Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient¿s implantable cardioverter defibrillator (icd) was operating in backup mode.Further information was requested but not yet received.
Event or Problem Description
New information indicates that the implantable cardioverter defibrillator (icd) was operating in backup mode due to the magnetic resonance imaging (mri) scan being performed without the icd being programmed to mri mode.Programming changes were made and the icd was restored.Patient¿s condition was not known.

• Brand Name: ELLIPSE DR ICD
• 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: 25598025
• Report Number: 2017865-2026-12976
• Device Sequence Number: 5534232
• Product Code: NVZ
• UDI-Device Identifier: 05414734507585
• UDI-Public: (01)05414734507585(10)A000121675(17)240229
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2026

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: 02/29/2024
• Device Model Number: CD2411-36C
• Device Catalogue Number: CD2411-36C
• Device Lot Number: A000121675
• 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: 06/03/2026
• Supplement Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 06/23/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2022
• 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
• Patient Age: 68 YR
• Patient Sex: Male