MAUDE Adverse Event Report: ABBOTT NEUTRINO NXT HF; No Match

Model Number CDHFA600Q

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Arrhythmia (1721); Discomfort (2330)

Event Date 08/22/2023

Event Type  malfunction  

Event Description

It was reported, the patient was experiencing palpitations and was attempting to send a remote transmission.It was noted the transmission was successful however, it was unable to be located.The transmission came through at a later time.The patient was stable.

• Brand Name: NEUTRINO NXT HF
• Type of Device: 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17744033
• MDR Text Key: 323381035
• Report Number: 2017865-2023-44060
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDHFA600Q
• Device Lot Number: P000161003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1