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	Signal Artifact/Noise (1036); High impedance (1291); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional information received indicated that the patient's implantable cardioverter defibrillator (icd) header had the anomalies of a high pacing impedance and noise.
Event or Problem Description
It was reported that the patient's implantable cardioverter defibrillator (icd) was found to have a bad header, resulting in anomalies.The icd was explanted and successfully replaced.The patient was stable.
Additional Manufacturer Narrative
The reported event was a bad header.The device was returned for analysis.Final analysis found the device to have appropriate remaining longevity and to be within normal range of operation.No anomalies were detected.

• 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: 50463994
• Report Number: 2017865-2026-17986
• Device Sequence Number: 10063512
• Product Code: NIK
• UDI-Device Identifier: 05415067050052
• UDI-Public: (01)05415067050052(10)A000179352(17)270930
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 09/14/2026

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: A000179352
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/10/2026
• 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: 08/06/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2025
• 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; Tendril; Ultipace
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female