MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) GALLANT BIPOLAR DF4 HF; No Match

Model Number	CDHFA500D
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented remotely.A remote transmission showed that the patient's implantable cardioverter defibrillator (icd) exhibited unspecified t-wave oversensing.No intervention was performed.The patient was stable throughout.

• Brand Name: GALLANT BIPOLAR DF4 HF
• Common Device Name: No Match
• 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: 25510734
• Report Number: 2017865-2026-12372
• Device Sequence Number: 16090171
• Product Code: NIK
• UDI-Device Identifier: 05415067050052
• UDI-Public: (01)05415067050052(10)A000179219(17)270930
• 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: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

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: CDHFA500D
• Device Catalogue Number: CDHFA500D
• Device Lot Number: A000179219
• 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: 05/27/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2025
• 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: ENIGMA.; LEFT VENTRICULAR LEAD.; ULTIPACE.
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 68 KG