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

Model Number	CDHFA600D
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient presented with over-sensing noted on the right ventricular lead and implantable cardioverter defibrillator.A minor arrythmia was noted.No intervention was noted and no information regarding adverse patient consequences were reported.
Event or Problem Description
New information received notes that intervention was unknown, and patient history was unknown.No indication of malfunction was alleged and the patient presented remotely.Over-sensing of ectopic beats was noted.

• 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: 24573458
• Report Number: 2017865-2026-04995
• Device Sequence Number: 13050961
• Product Code: NIK
• 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: P030054
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: 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: 02/18/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/01/2026
• 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
• Patient Sex: Unknown