MAUDE Adverse Event Report: ABBOTT ENTRANT VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CDVRA300Q

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

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

Event Date 08/09/2021

Event Type  malfunction  

Event Description

During an in-clinic follow-up, the device was found to be in telemetry lockout due to excessive bluetooth low energy (ble) telemetry.Upon interrogation, the programmer noted ble communication was reenabled, however, the device was unable to be interrogated via ble telemetry.The device was interrogated via inductive telemetry in order to complete the follow-up.No further intervention was performed at this time.The patient was stable and will continue to be monitored.

Manufacturer Narrative

The reported event of unable to communicate via bluetooth telemetry was confirmed.The device was not returned for analysis, however, device logs were reviewed and determined there was a memory corruption.

• Brand Name: ENTRANT VR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 12356660
• MDR Text Key: 267813912
• Report Number: 2017865-2021-28292
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032836
• UDI-Public: 05415067032836
• 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

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: CDVRA300Q
• Device Catalogue Number: CDVRA300Q
• Device Lot Number: S000076941
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1