MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Unify Assura CRT-D RF HV; Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

Model Number	CD3357-40C
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Under-Sensing (1661)
Health Effect - Clinical Code	Arrhythmia (1721)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was admitted to the intensive care unit for cardiac arrest.It was found that the implantable cardioverter defibrillator (icd) exhibited undersensing which resulted in delayed treatment of arrythmia.It was determined that this undersensingfwas due to inappropriate programming settings and the device was reprogrammed.The patient was stable following changes.

• Brand Name: Unify Assura CRT-D RF HV
• 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: 50314601
• Report Number: 2017865-2026-17393
• Device Sequence Number: 9864637
• Product Code: NIK
• UDI-Device Identifier: 05414734508186
• UDI-Public: (01)05414734508186(10)A000045849(17)190930
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2026

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: 09/30/2019
• Device Model Number: CD3357-40C
• Device Catalogue Number: CD3357-40C
• Device Lot Number: A000045849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Biomec Lead; Biomec Lead; Tendril
• Patient Sex: Female