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	Over-Sensing (1438)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that post paced t wave oversensing was observed on the implantable cardioverter defibrillator (icd).
Additional Manufacturer Narrative
Further information was requested but was not available at this time.

• 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: 25402876
• Report Number: 2017865-2026-11677
• Device Sequence Number: 13373138
• Product Code: NVZ
• UDI-Device Identifier: 05414734508063
• UDI-Public: (01)05414734508063(10)A000108062(17)230331
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: CD2357-40C
• Device Catalogue Number: CD2357-40C
• Device Lot Number: A000108062
• 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: 05/19/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2021
• 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: MED 5076.; MED 6949.
• Patient Sex: Male