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

Model Number CDDRA600Q

Device Problems Failure to Interrogate (1332); Wireless Communication Problem (3283)

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

Event Date 06/07/2021

Event Type  malfunction  

Event Description

During an in clinic follow-up, excessive bluetooth use was detected on the device.Interrogation was attempted but the device was unable to communicate via bluetooth telemetry.However, the device was able to be interrogated using inductive telemetry.The patient was in stable condition.

Manufacturer Narrative

The reported event of unable to communicate via bluetooth telemetry and lockout were confirmed.The logs were reviewed and determined there was a memory corruption which resulted in connection errors.The connection errors led to a cyber lockout, however, this does not affect device therapy functions.

• Brand Name: NEUTRINO NXT DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 12046035
• MDR Text Key: 257734736
• Report Number: 2017865-2021-23804
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

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: 10/31/2022
• Device Model Number: CDDRA600Q
• Device Lot Number: S000079138
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 09/10/2021
• Supplement Dates FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1