MAUDE Adverse Event Report: ABBOTT UNIFY ASSURA ICD; No Match

Model Number CD3361-40C

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

Patient Problems Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/12/2024

Event Type  Injury  

Event Description

It was reported that the patient had an device pocket injury.Infection was suspected but was not confirmed.The device was explanted and replaced to resolve the vent.The patient was stable and there were no adverse consequences.

Manufacturer Narrative

Additional information was requested but was not available.

• Brand Name: UNIFY ASSURA ICD
• 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: 19209662
• MDR Text Key: 341351205
• Report Number: 2017865-2024-40010
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508223
• UDI-Public: (01)05414734508223(10)A000097480(17)220531
• 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: Physician
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: CD3361-40C
• Device Lot Number: A000097480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2020
• 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
• Patient Outcome(s): Required Intervention