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

Model Number CDVRA600Q

Device Problem Incorrect Measurement (1383)

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

Event Date 01/29/2023

Event Type  malfunction  

Manufacturer Narrative

The reported event of the diagnostic anomaly was confirmed.Based on the information provided, it was determined that the displayed value for last max charge was rounded from original value; thus, it does not appear to have changed, which led to the confusion of why the value was not updated from the last check.The device is performing per design.

Event Description

During an in clinic follow up, a diagnostic anomaly was noted on the device.Technical support was contacted and recommended further investigation.No intervention has been performed.The patient was stable and will continue being monitored.

• Brand Name: NEUTRINO NXT VR
• 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: 16567805
• MDR Text Key: 311559456
• Report Number: 2017865-2023-14013
• 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
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: CDVRA600Q
• Device Lot Number: S000079072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• 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