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

Model Number CD3361-40C

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Under-Sensing (1661)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  Injury  

Event Description

It was reported that functional undersensing and inappropriate antitachycardia pacing delivered for supraventricular tachycardia was observed on device.No allegation of malfunction was made against the device.No intervention has been performed at this time to resolve the event.The patient was in stable condition and will continue to be monitored.

• 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: 18416865
• MDR Text Key: 331576035
• Report Number: 2017865-2023-95690
• Device Sequence Number: 1
• Product Code: NIK
• 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
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: CD3361-40C
• Device Lot Number: P000145392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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