MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Entrant VR; Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

Model Number	CDVRA300Q
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Codes	Arrhythmia (1721); Heart Failure/Congestive Heart Failure (4446)
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient presented for initial implantable cardioverter defibrillator (icd) and right ventricular (rv) lead implant on (b)(6) 2026.The following day, the patient's icd inappropriately went into backup operation with high voltage therapies disabled.It was suspected that the cause of backup operation was the icd delivering too many appropriate shocks to the patient.The patient was found deceased after being discharged from the hospital on (b)(6) 2026.The cause of death was suspected to be either progression of underlying heart failure or the patient being in slow ventricular tachycardia (vt) that went untreated by the icd.

• Brand Name: Entrant VR
• Common Device Name: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
• 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: 50479157
• Report Number: 2017865-2026-18065
• Device Sequence Number: 13290115
• Product Code: NIK
• UDI-Device Identifier: 05415067032836
• UDI-Public: (01)05415067032836(10)P000239345(17)270731
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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 Model Number: CDVRA300Q
• Device Catalogue Number: CDVRA300Q
• Device Lot Number: P000239345
• 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: 08/07/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown