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

Model Number CDHFA600Q

Device Problems Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959); Data Problem (3196)

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

Event Type  malfunction  

Event Description

During an in-clinic follow-up, the device was found to be in backup vvi (bvvi) mode due to off-label magnetic resonance imaging (mri) exposure.Abbott technical support was contacted, and the device was reprogrammed.After reprogramming, the device delivered an error message when attempting to use the "send command" function.The cause of the observed error message was unknown.The patient was in stable condition.

Manufacturer Narrative

The reported event of an unrecoverable error occuring during an attempt to program was confirmed.The provided logs and session records were reviewed by abbott engineering and it was noted that the user had not written the data into the device, therefore the error was occurring.The error occurs on the programmer application before the command is sent to the device.There is no device malfunction suspected.

• 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: 18084953
• MDR Text Key: 327540690
• Report Number: 2017865-2023-51815
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

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: 01/31/2023
• Device Model Number: CDHFA600Q
• Device Lot Number: S000080701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 12/15/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2021
• 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