MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) FORTIFY ASSURA DR ICD, US; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	CD2357-40C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the icd detected one episode of ventricular fibrillation (vf) that appeared to be polymorphic ventricular tachycardia (pmvt).The device initially attempted antitachycardia pacing (atp), which was unsuccessful.It then delivered a 36-joule shock, which successfully converted the rhythm to atrial fibrillation with ventricular sensing (afvs) and ventricular pacing (vp) at a controlled rate.At the time of the event, the patient was found unresponsive for approximately 30 seconds.Upon waking, the patient denied any immediate symptoms.Normal device function was noted.The device was later electively explanted and replaced.No patient condition was reported.
Additional Manufacturer Narrative
The device was returned due to an adverse event without an identified device or use problem.The device was received with normal output and normal telemetry.Analysis of the device image was performed, and no anomalies were noted.Further electrical testing was performed, including lead impedance, high voltage shock, output and sensitivity test, and no issues were noted.Longevity assessment found the device was operating above the elective replacement indicator (eri) voltage, consistent with normal usage.

• 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: 25218835
• Report Number: 2017865-2026-10459
• Device Sequence Number: 15900692
• Product Code: NVZ
• UDI-Device Identifier: 05414734508063
• UDI-Public: (01)05414734508063(10)A000025031(17)180731
• 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: 2016
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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: 07/31/2018
• Device Model Number: CD2357-40C
• Device Catalogue Number: CD2357-40C
• Device Lot Number: A000025031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• 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: 04/29/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2016
• 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: GUIDANT RV LEAD; TENDRIL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male