MAUDE Adverse Event Report: ABBOTT UNIFY ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3361-40C

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Syncope (1610); Arrhythmia (1721)

Event Date 11/27/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

During an in clinic follow-up, the device was being interrogated and many stored episodes were being downloaded.The patient experienced ventricular tachycardia (vt) and the physician attempted to provide non-invasive pacing stimulation, however, this was unavailable due to the loading episodes.The patient began experiencing syncope and the physician had to deliver external defibrillation to resolve vt and syncope.The loading of the episodes completed and the event was resolved.The patient was in stable condition following the event.

• Brand Name: UNIFY ASSURA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 10987952
• MDR Text Key: 220884951
• Report Number: 2938836-2020-09561
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: CD3361-40C
• Device Lot Number: A000029320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2016
• 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