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

Model Number CDHFA500Q

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/19/2022

Event Type  Injury  

Event Description

Related manufacturer report number: 2017865-2022-40177, 2017865-2022-40178, 2017865-2022-40179.It was reported that the patient experienced acute venous thrombosis and swelling on the upper torso following an implant procedure.The physician alleges the event is related to the system implant procedure.The patient was administered medication to resolve the event and the patient was in stable condition.

• 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: 15559293
• MDR Text Key: 301329816
• Report Number: 2017865-2022-40180
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032010
• UDI-Public: 05415067032010
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CDHFA500Q
• Device Catalogue Number: CDHFA500Q
• Device Lot Number: P000152729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• 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