MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Gallant Bipolar DF4 HF; Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

Model Number	CDHFA500D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pocket Erosion (2013)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient presented to clinic with pocket erosion and infection.A small hole was identified in the skin near the incision scar from the implantable cardioverter defibrillator (icd) implantation.The patient confirmed non-compliance with post-discharge instructions.As a result, the icd, right ventricular (rv), right ventricular left bundle branch pacing (rv-lbbp) and right atrial (ra) leads were explanted on (b)(6) 2026.Echocardiography findings indicated no vegetation on the leads.The explanted system was submitted for pathological evaluation related to the infection.The physician did not specify the cause of the infection or indicate whether the event was related to an abbott product or procedure.The patient was stable throughout the procedure.
Additional Manufacturer Narrative
A device history record (dhr) review was performed and review of the sterilization records confirmed normal sterilization cycles for the products.The device met specifications prior to leaving abbott manufacturing facilities.The results of the investigation are inconclusive since the device was not returned for analysis.

• Brand Name: Gallant Bipolar DF4 HF
• 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: 50705334
• Report Number: 2017865-2026-19130
• Device Sequence Number: 13411443
• Product Code: NIK
• UDI-Device Identifier: 05415067050052
• UDI-Public: (01)05415067050052(10)A000183985(17)280131
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 09/10/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: CDHFA500D
• Device Catalogue Number: CDHFA500D
• Device Lot Number: A000183985
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2026
• 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: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male