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

Model Number CDHFA300Q

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

Patient Problems Wound Dehiscence (1154); Hematoma (1884); Discomfort (2330)

Event Date 05/25/2023

Event Type  Injury  

Event Description

During an in-clinic follow-up, inflammation was noted around the incision site of the device pocket.A revision procedure was performed to remove blood clots and reposition the device.The patient was in stable condition.

Event Description

Additional information received indicated the patient experienced pain and discomfort at the implant site due to the hematoma.

• Brand Name: ENTRANT 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17106500
• MDR Text Key: 316978979
• Report Number: 2017865-2023-22906
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032850
• UDI-Public: 05415067032850
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CDHFA300Q
• Device Catalogue Number: CDHFA300Q
• Device Lot Number: P000158909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2022
• 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): Required Intervention