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

Model Number CDVRA500Q

Device Problem Wireless Communication Problem (3283)

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

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information and records received, the reported event of unable to interrogate via ble was confirmed.The logs were reviewed and determined there was a message integrity check (mic) error which resulted in connection errors, which ultimately led to a cyber lockout.The cause of the mic error is underdetermined.Based on the result of these findings, abbott is performing further investigation.

Event Description

During an in clinic follow-up, the device was found to be in bluetooth (ble) lockout.However, the device was able to be interrogated using inductive telemetry.The patient was in stable condition.

Event Description

Additional information was received that the device bluetooth was reset to resolve the event.The patient was stable.

• Brand Name: GALLANT 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12161646
• MDR Text Key: 261461511
• Report Number: 2017865-2021-25239
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067031990
• UDI-Public: 05415067031990
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

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: 05/31/2022
• Device Model Number: CDVRA500Q
• Device Catalogue Number: CDVRA500Q
• Device Lot Number: S000076792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2020
• 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