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

Model Number CDHFA500Q

Device Problems Failure to Capture (1081); No Pacing (3268)

Patient Problem Arrhythmia (1721)

Event Date 06/24/2022

Event Type  Injury  

Event Description

During an in clinic follow-up, a left ventricular capture testing was performed and loss of capture occurred which resulted in the patient experiencing asystole.The device had no backup pulse to prevent the loss of capture and the test was terminated by the healthcare provider to resolve the event.The patient was stable and experienced no adverse consequence due to the asystole.

Manufacturer Narrative

The report of lack of ¿back-up¿ safety pacing when running lvcap confirm set-up test when programmed to lv only was confirmed.A software investigation was performed by reviewing session records and/or data logs provided from the customer.The event was a result of a software anomaly where the parameter that ensures delivery of an high output rv pulse when running lvcap confirm was not set correctly.

• Brand Name: GALLANT 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14957812
• MDR Text Key: 295502687
• Report Number: 2017865-2022-13771
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032010
• UDI-Public: 05415067032010
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: CDHFA500Q
• Device Catalogue Number: CDHFA500Q
• Device Lot Number: S000080864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 11/20/2022
• Supplement Dates FDA Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• 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
• Patient Outcome(s): Other; Required Intervention