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

Model Number CDHFA600Q

Device Problems High impedance (1291); Over-Sensing (1438); Failure to Sense (1559); Under-Sensing (1661); No Pacing (3268)

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

Event Date 01/26/2023

Event Type  Injury  

Event Description

During a remote follow-up, episodes of oversensing and undersensing, an increased pacing and defibrillation impedance, a loss of sensing, and a loss of pacing were observed on the device.The device was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.

Manufacturer Narrative

The reported event of out-of-range high voltage lead impedance (hvli) and out-of-range pacing lead impedances (pli) could not be confirmed.The reported event of oversensing was confirmed.Analysis of the device image by abbott technical services confirmed oversensing in the ventricular channel, but this was not due to a device anomaly.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and revealed to be normal.

• 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: 16294993
• MDR Text Key: 308761123
• Report Number: 2017865-2023-04984
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDHFA600Q
• Device Lot Number: P000154190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2022
• 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
• Patient Outcome(s): Required Intervention