MAUDE Adverse Event Report: ABBOTT NEUTRINO NXT BIPOLAR DF4 HF; NO MATCH

Model Number	CDHFA600D
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
It was reported, the device was unable to be connected via bluetooth telemetry to the remote monitoring application.No intervention has been performed at this time.The patient was stable.
Additional Manufacturer Narrative
The reported event of incomplete device checks was confirmed.Based on the information provided, it was determined that there were connectivity errors.The root cause of the error was unable to be determined.

• Brand Name: NEUTRINO NXT BIPOLAR DF4 HF
• Common Device Name: NO MATCH
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 23639984
• Report Number: 2017865-2025-1005870
• Device Sequence Number: 15932169
• Product Code: NIK
• UDI-Device Identifier: 05415067050045
• UDI-Public: (01)05415067050045(10)S000101356(17)270131
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup,Followup
• Report Date (Section B): 03/23/2026

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: S000101356
• 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: 11/09/2025
• Supplement Date Received by Manufacturer: 11/26/2025; 12/09/2025; 03/20/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/08/2025; 12/10/2025; 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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