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

Model Number CD3361-40QC

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

Patient Problem Arrhythmia (1721)

Event Date 03/06/2024

Event Type  Injury  

Event Description

During a remote follow-up, the patient experienced a ventricular tachycardia (vt) episode.The device did not deliver any therapy because the vt was in the programmed monitor zone.External defibrillation was used to terminate the vt.Technical support was contacted and confirmed the device behaved according to its programmed settings and that no device malfunction was suspected.The device was reprogrammed to resolve the event.The patient was stable 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: 18961157
• MDR Text Key: 338380793
• Report Number: 2017865-2024-35664
• Device Sequence Number: 1
• Product Code: NIK
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD3361-40QC
• Device Lot Number: A000132905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2022
• 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