MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Fortify Assura DR ICD, US; Pulse Generator, Permanent, Implantable

Model Number	CD2357-40C
Medical Device Problem Codes	Failure to Convert Rhythm (1540); Low impedance (2285)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	08/25/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the right ventricular (rv) lead's high voltage (hv) impedance was observed to be low via remote monitoring.The patient was noted to be in ventricular fibrillation (vf) and the implantable cardioverter defibrillator (icd) attempted to shock.On the third attempt the patient did convert successfully in the right ventricular (rv) to superior vena cava (svc) shocking vector.The patient was in and out of vf since 1:00 pm that day and the observation was made at 11:50 pm.A transmission at 2:00 am noted a normal rhythm.The clinician contacted the patient, and it was noted that the patient had passed away in the middle of the night.

• Brand Name: Fortify Assura DR ICD, US
• Common Device Name: Pulse Generator, Permanent, Implantable
• 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: 50704857
• Report Number: 2017865-2026-19123
• Device Sequence Number: 21485641
• Product Code: NVZ
• UDI-Device Identifier: 05414734508063
• UDI-Public: (01)05414734508063(10)A000020168(17)180331
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• 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
• Report Date (Section B): 09/09/2026

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: 03/31/2018
• Device Model Number: CD2357-40C
• Device Catalogue Number: CD2357-40C
• Device Lot Number: A000020168
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2016
• 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: Female