MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) ENTRANT VR; No Match

Model Number	CDVRA300Q
Medical Device Problem Codes	Inappropriate or Unexpected Reset (2959); Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Following a magnetic resonance imaging (mri), the device was found to be in backup vvi mode (bvvi) resulting in high-voltage (hv) therapy being disabled.Technical support was contacted, and the device was reprogrammed to resolve the event.The patient was stable with no consequences.

• Brand Name: ENTRANT VR
• 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: 25647900
• Report Number: 2017865-2026-13322
• Device Sequence Number: 9838920
• Product Code: NIK
• UDI-Device Identifier: 05415067032836
• UDI-Public: (01)05415067032836(10)P000170956(17)250531
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2026

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: 05/31/2025
• Device Model Number: CDVRA300Q
• Device Catalogue Number: CDVRA300Q
• Device Lot Number: P000170956
• 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: 06/19/2026
• Initial Report FDA Received Date: 06/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2023
• 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
• Patient Sex: Unknown