MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Gallant VR; Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

Model Number	CDVRA500Q
Medical Device Problem Code	Failure to Convert Rhythm (1540)
Health Effect - Clinical Codes	Arrhythmia (1721); Discomfort (2330)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had experienced ventricular tachycardia (vt), the device delivered high voltage therapy, however the shock did not initially convert the vt.Additional shocks were delivered which converted the patient to sinus rhythm.The patient reported chest pain during the event.Reprogramming is anticipated to resolve the event.No intervention has been performed.The patient is stable.
Event or Problem Description
Additional information was received that the device was reprogrammed to resolve the event.

• Brand Name: Gallant VR
• Common Device Name: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
• 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: 50789460
• Report Number: 2017865-2026-19086
• Device Sequence Number: 15813233
• Product Code: NIK
• UDI-Device Identifier: 05415067031990
• UDI-Public: (01)05415067031990(10)P000230735(17)270331
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: P030054
• 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: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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 Model Number: CDVRA500Q
• Device Catalogue Number: CDVRA500Q
• Device Lot Number: P000230735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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
• Patient Sex: Unknown