MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) GALLANT¿ DR; Implantable cardioverter defibrillator (non-CRT)

Model Number	CDDRA500T
Medical Device Problem Code	Failure to Convert Rhythm (1540)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the emergency department with ventricular tachycardia (vt).The implantable cardioverter defibrillator (icd) and right ventricular (rv) lead failed to convert the patient¿s rhythm and external defibrillation was used.Device interrogation revealed that the rv lead had failed to capture.On (b)(6) 2026, the physician capped and replaced the rv lead.During this procedure, fluoroscopy was performed noting insulation breaks on the right atrial (ra) lead.No anomalies were noted on the rv lead via fluoroscopy.Additionally, ra lead noise was noted during manipulation.The physician elected to cap and replace the ra lead during the same procedure.The patient condition was stable before, during, and after the procedure.

• Brand Name: GALLANT¿ DR
• 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: 24824002
• Report Number: 2017865-2026-07315
• Device Sequence Number: 15841875
• Product Code: LWS
• UDI-Device Identifier: 05415067049476
• UDI-Public: (01)05415067049476(10)S000097570(17)260731
• 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: 2025
• 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): 04/08/2026

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: 07/31/2026
• Device Model Number: CDDRA500T
• Device Catalogue Number: CDDRA500T
• Device Lot Number: S000097570
• 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: 03/20/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2024
• 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: Life Threatening
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White