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

Model Number	CD2357-40C
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Codes	Dyspnea (1816); Dizziness (2194)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
It was reported that far r-wave oversensing and inappropriate automatic mode switch (ams) was noted on the implantable cardioverter defibrillator (icd).The oversensing resulted in pacing inhibition.Additionally, the patient was symptomatic, including dizziness and shortness of breath.Programming changes were performed to resolve the issue.The patient condition was unknown.
Event or Problem Description
New information received noted that the patient condition was stable before, during, and after the changes.

• 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: 24960779
• Report Number: 2017865-2026-08366
• Device Sequence Number: 10199514
• Product Code: NVZ
• UDI-Device Identifier: 05414734508063
• UDI-Public: (01)05414734508063(10)A000055621(17)200131
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: 01/31/2020
• Device Model Number: CD2357-40C
• Device Catalogue Number: CD2357-40C
• Device Lot Number: A000055621
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2018
• 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: RA LEAD.; RV LEAD.
• Patient Age: 59 YR
• Patient Sex: Male