MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 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	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) exhibited bluetooth (ble) telemetry loss.The icd was interrogated using wand only telemetry.There were no patient consequences reported.
Additional Manufacturer Narrative
The reported event of the merlin 2 programmer being unable to interrogate the implanted device was confirmed.Based on the information provided, it was determined that the connectivity issue was due to an intel bluetooth firmware issue on the programmer.The implanted device was performing per design.

• 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: 24394101
• Report Number: 2017865-2026-03497
• Device Sequence Number: 13212239
• Product Code: NIK
• UDI-Device Identifier: 05415067050045
• UDI-Public: (01)05415067050045(10)S000102872(17)270331
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: S000102872
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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: MERLIN¿ 2 PATIENT CARE SYSTEM (PCS) PROGRAMMER.
• Patient Sex: Unknown