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

Model Number CD3367-40QC

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

Patient Problem Unspecified Infection (1930)

Event Date 04/02/2024

Event Type  Injury  

Manufacturer Narrative

The sterilization records were reviewed and no evidence of abnormal sterilization cycle was found.

Event Description

It was reported that the device, right atrial (ra) lead, and right ventricular (rv) lead were explanted due to a pocket infection.The physician alleged the infection was not related to any product in the system or the implant procedure.The patient was in stable condition.

• Brand Name: QUADRA 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: 19182580
• MDR Text Key: 341054899
• Report Number: 2017865-2024-39644
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508322
• UDI-Public: (01)05414734508322(10)P000175892(17)250630
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/25/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: CD3367-40QC
• Device Lot Number: P000175892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/19/2023
• 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; Other