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	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an unrelated revision procedure of the right ventricular (rv) lead, the rv set screw was not able to engage with the rv lead when inserted into the header of the device.The device was explanted and replaced to resolve this event.The patient was stable.

• 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: 50884023
• Report Number: 2017865-2026-20289
• Device Sequence Number: 18582518
• Product Code: NIK
• UDI-Device Identifier: 05415067031990
• UDI-Public: (01)05415067031990(10)P000218444(17)261031
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: P000218444
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2024
• 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
• Patient Sex: Unknown