MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) FORTIFY ASSURA VR ICD, US; Implantable cardioverter defibrillator (non-CRT)

Model Number	CD1357-40C
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Codes	Arrhythmia (1721); Syncope/Fainting (4411)
Date of Event	04/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced syncope and ventricular tachycardia (vt).Review of the transmission revealed loss of high-voltage (hv) therapy on the patient¿s implantable cardioverter defibrillator (icd) as the vt was outside of the detection rate.Programming changes were discussed, no intervention was reported.The patient¿s condition remained stable.

• 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: 25062212
• Report Number: 2017865-2026-08960
• Device Sequence Number: 10101313
• Product Code: LWS
• UDI-Device Identifier: 05414734507943
• UDI-Public: (01)05414734507943(10)A000022998(17)180531
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 05/01/2026

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: 05/31/2018
• Device Model Number: CD1357-40C
• Device Catalogue Number: CD1357-40C
• Device Lot Number: A000022998
• 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: 04/15/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RV LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male