MAUDE Adverse Event Report: ABBOTT GALLANT HF; NO MATCH

Model Number CDHFA500Q

Device Problem Failure to Convert Rhythm (1540)

Patient Problem Syncope/Fainting (4411)

Event Date 02/23/2024

Event Type  Injury  

Event Description

It was reported that the patient experienced syncope.The device delivered appropriate high voltage therapy that failed to convert the arrhythmia.The arrhythmia self-terminated.Device reprogramming was anticipated to resolve the event.No intervention was performed; the patient was stable and will continue to be monitored.

Event Description

It was reported that the patient experienced syncope.The device delivered appropriate high voltage therapy that failed to convert the arrhythmia.The arrhythmia self-terminated.The device was reprogrammed to resolve the event.No intervention was performed; the patient was stable and will continue to be monitored.

• Brand Name: GALLANT HF
• Type of Device: NO MATCH
• 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: 18888315
• MDR Text Key: 337471937
• Report Number: 2017865-2024-34775
• 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,Followup
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: CDHFA500Q
• Device Lot Number: S000076627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2020
• 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