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

Model Number CDHFA600Q

Device Problems Failure to Charge (1085); Failure to Convert Rhythm (1540)

Patient Problem Arrhythmia (1721)

Event Date 10/06/2022

Event Type  malfunction  

Event Description

During a clinic follow-up, inadequate high voltage (hv) output was observed on the device.Additionally, a charge time out alert was observed on the device.Technical support was contacted and the patient's drug therapy was modified to resolve the event.The patient was stable and will continue to be monitored.

Event Description

Additional information was received that induction testing was performed on the device, but no further intervention has been performed at this time.The patient was stable.

Event Description

Additional information was provided that the device was reprogrammed.

• 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: 15708485
• MDR Text Key: 306353181
• Report Number: 2017865-2022-42939
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: CDHFA600Q
• Device Lot Number: P000136720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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