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

Model Number	CD2357-40Q
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Deliver Shock/Stimulation (1133); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Arrhythmia (1721)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a ventricular tachycardia (vt) episode and presented to the emergency room.Upon examination, it was observed that the implantable cardioverter defibrillator (icd) did not deliver shock therapy because the patient's vt episode is slower than the programmed settings for high voltage therapy.The device detection and therapy was reprogrammed.Further review showed that the icd had noise on the atrial channel and inappropriate anti-tachycardia pacing (atp) and shock were delivered.No intervention was performed for the noise anomaly and subsequent shock as the patient is being hospitalized for a scheduled vt ablation procedure.The patient's condition was stable.

• 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: 50168264
• Report Number: 2017865-2026-16556
• Device Sequence Number: 20146795
• Product Code: NVZ
• UDI-Device Identifier: 05414734508094
• UDI-Public: (01)05414734508094(10)A000063619(17)200831
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/06/2026

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: 08/31/2020
• Device Model Number: CD2357-40Q
• Device Catalogue Number: CD2357-40Q
• Device Lot Number: A000063619
• 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: 07/15/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2018
• 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: Optisure; Tendril
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Male