MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Neutrino NxT Bipolar DF1 HF; Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

Model Number	CDHFA600B
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a routine generator change, upon connecting a right atrial (ra) lead, far field r-wave oversensing was observed on the newly implanted implantable cardioverter defibrillator (icd).This had not been observed on the older generator though all settings mirrored the original generator.Programming changes were made.There were no complaints on the ra lead.The new icd remained implanted and was being monitored.The procedure was not prolonged and there were no patient consequences.

• Brand Name: Neutrino NxT Bipolar DF1 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: 50533853
• Report Number: 2017865-2026-18311
• Device Sequence Number: 17652315
• Product Code: NIK
• UDI-Device Identifier: 05415067050076
• UDI-Public: (01)05415067050076(10)S000106601(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: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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: CDHFA600B
• Device Catalogue Number: CDHFA600B
• Device Lot Number: S000106601
• 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: 08/12/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2025
• 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: Durata RV lead; Quickflex LV lead; Tendril ST RA lead
• Patient Sex: Unknown