MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) NEUTRINO NXT HF; No Match

Model Number CDHFA600Q

Device Problem Under-Sensing (1661)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2024

Event Type  malfunction  

Event Description

It was reported that episodes of vt due to under-sensing was noted on the device.Programming changes were made.There were no adverse health consequences, the patient was stable.

• Brand Name: NEUTRINO NXT HF
• Type of Device: 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18711737
• MDR Text Key: 335934039
• Report Number: 2017865-2024-32745
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: CDHFA600Q
• Device Lot Number: S000081166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1