MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Fortify Assura VR ICD, US; Implantable Cardioverter Defibrillator (Non-Crt)

Model Number	CD1357-40Q
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Under-Sensing (1661)
Health Effect - Clinical Codes	Arrhythmia (1721); Syncope/Fainting (4411)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced arrhythmia and syncope episode and presented in the emergency room.It was noted that the implantable cardioverter defibrillator (icd) exhibited under-sensing and failed to deliver therapy.Programming changes were made.The patient was in stable condition.

• Brand Name: Fortify Assura VR ICD, US
• Common Device Name: Implantable Cardioverter Defibrillator (Non-Crt)
• 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: 50037868
• Report Number: 2017865-2026-15650
• Device Sequence Number: 15939249
• Product Code: LWS
• UDI-Device Identifier: 05414734507974
• UDI-Public: (01)05414734507974(10)4864354(17)161031
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 07/27/2026

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: 10/31/2016
• Device Model Number: CD1357-40Q
• Device Catalogue Number: CD1357-40Q
• Device Lot Number: 4864354
• 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: 07/06/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2014
• 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: Other
• Patient Sex: Unknown