MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) ENTRANT DR; NO MATCH

Model Number	CDDRA300Q
Medical Device Problem Codes	Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient presented with back-up vvi mode noted on the patient's implantable cardioverter defibrillator following magnetic resonance imaging (mri) in an off-label environment, as the device was not switched into mri mode.Reprogramming was not successful so a generator change was planned.It was then reported the patient deceased due to underlying medical complications.There is no known allegation from a health professional that suggests the death was related to the device.

• Brand Name: ENTRANT DR
• Common Device Name: NO MATCH
• 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: 24678153
• Report Number: 2017865-2026-06004
• Device Sequence Number: 10071399
• Product Code: NIK
• UDI-Device Identifier: 05415067032843
• UDI-Public: (01)05415067032843(10)P000184978(17)251031
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2026

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: 10/31/2025
• Device Model Number: CDDRA300Q
• Device Catalogue Number: CDDRA300Q
• Device Lot Number: P000184978
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 06/25/2026; 07/17/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 06/25/2026; 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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: Death
• Patient Sex: Unknown