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	Stroke/CVA (1770)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
It was reported that the patient presented for in clinic follow-up.On (b)(6) 2026, and magnetic resonance imaging (mri) scan was performed after the patient experienced a stroke; however, the implantable cardioverter defibrillator (icd) was not mri-compatible.Device interrogation later revealed that the icd was in backup mode with high voltage (hv) therapies disabled.Programming changes were performed to resolve the issue.There were no patient consequences reported.

• 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: 25260490
• Report Number: 2017865-2026-10853
• Device Sequence Number: 21467983
• Product Code: NIK
• UDI-Device Identifier: 05415067032843
• UDI-Public: (01)05415067032843(10)P000228289(17)270228
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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 Model Number: CDDRA300Q
• Device Catalogue Number: CDDRA300Q
• Device Lot Number: P000228289
• 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: 05/04/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• 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 Sex: Unknown