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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was admitted to the hospital with a fever and signs of infection.Vegetation was noted on the right ventricular (rv) lead via diagnostic imaging.It was also observed that the rv lead exhibited noise oversensing, resulting in pacing inhibition.The implantable cardioverter defibrillator (icd) and the rv lead were explanted on (b)(6) 2026.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: 50383208
• Report Number: 2017865-2026-17694
• Device Sequence Number: 13208883
• Product Code: LWS
• UDI-Device Identifier: 05414734507974
• UDI-Public: (01)05414734507974
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• 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): 08/21/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: CD1357-40Q
• Device Catalogue Number: CD1357-40Q
• Device Lot Number: A000074466
• 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: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2019
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female