MAUDE Adverse Event Report: ABBOTT NEUTRINO NXT HF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CDHFA600Q

Device Problems Failure to Interrogate (1332); No Apparent Adverse Event (3189)

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

Event Date 06/06/2023

Event Type  malfunction  

Event Description

During an in-clinic follow-up, the device was unable to be paired with the remote monitoring smartphone application and was unable to be interrogated via bluetooth low energy (ble) telemetry.No intervention was performed at this time.The patient was stable and will continue to be monitored.

Manufacturer Narrative

Correction: upon review, the pulse generator should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.

Event Description

Additional information received indicated the patient was later seen in-clinic where ble telemetry was operating successfully.The device communicated normally with the merlin programmer and abbott provided smartphone.The cause of the reported event was due to the patient's smartphone.The patient was in stable condition.

• Brand Name: NEUTRINO NXT HF
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 17145950
• MDR Text Key: 317660156
• Report Number: 2017865-2023-23441
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 07/10/2023

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: 10/31/2023
• Device Model Number: CDHFA600Q
• Device Lot Number: P000133520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2021
• 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