MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ENTRANT BIPOLAR DF1 HF; NO MATCH

Model Number	CDHFA300B
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for initial implant procedure.During the procedure, the implantable cardioverter defibrillator (icd) failed to be interrogated.This icd was not used, and the physician completed the procedure using a different icd.There were no patient consequences noted.
Additional Manufacturer Narrative
Reported complaint of inability to interrogate was not confirmed.The device was received in normal range of operation.Analysis of device image was performed and no anomalies were noted.Further electrical testing was performed, including impedance and output testing, and no issues were noted.Longevity assessment found the device was operating above elective replacement indicator (eri) level and within expected longevity.

• Brand Name: ENTRANT BIPOLAR DF1 HF
• Common Device Name: NO MATCH
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 23790808
• Report Number: 2017865-2025-1007198
• Device Sequence Number: 10465159
• Product Code: NIK
• UDI-Device Identifier: 05415067050106
• UDI-Public: (01)05415067050106(10)S000107410(17)270731
• Combination Product (Y/N): N
• Initial Reporter Country: KZ
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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: CDHFA300B
• Device Catalogue Number: CDHFA300B
• Device Lot Number: S000107410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2025
• 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
• Patient Sex: Unknown