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 Codes	Failure to Capture (1081); Incorrect Measurement (1383); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Codes	Arrhythmia (1721); Dizziness (2194); Syncope/Fainting (4411)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the emergency room is bradycardia.Transmission revealed that the patient was in complete heart block and had both near syncopal and syncopal events.The patient's implantable cardioverter defibrillator (icd) had exhibited a failure to capture and had displayed incorrect capture measurements.It was also noted that the icd was in backup mode.Device programming changes were performed and the patient was stable.

• 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: 50938353
• Report Number: 2017865-2026-20656
• Device Sequence Number: 18831268
• Product Code: NIK
• UDI-Device Identifier: 05415067050052
• UDI-Public: (01)05415067050052(10)S000105622(17)270531
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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 Model Number: CDHFA500D
• Device Catalogue Number: CDHFA500D
• Device Lot Number: S000105622
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Optisure MRI; UltiPace; UltiPace MRI
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Male