MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) NEUTRINO NXT BIPOLAR DF4 HF; NO MATCH

Model Number	CDHFA600D
Medical Device Problem Code	Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that under-sensing was noted on the implantable cardioverter defibrillator (icd) and right ventricular (rv) lead.No intervention was reported, and the patient will continue to be monitored.The patient condition was unknown.
Event or Problem Description
New information received noted that a re-occurrence of under-sensing was noted on the icd and rv lead.Ventricular tachycardia (vt) ablation was performed to address the issue, however, was unsuccessful.Programming changes were performed to resolve the issue instead, and the patient will continue to be monitored.The patient condition was stable.

• Brand Name: NEUTRINO NXT BIPOLAR DF4 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: 23904047
• Report Number: 2017865-2025-1008274
• Device Sequence Number: 7707383
• Product Code: NVY
• UDI-Device Identifier: 05415067050045
• UDI-Public: (01)05415067050045(10)S000106272(17)270630
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/19/2026

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: CDHFA600D
• Device Catalogue Number: CDHFA600D
• Device Lot Number: S000106272
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 12/28/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown