MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA ICD; NO MATCH

Model Number CD3367-40QC

Device Problem Failure to Convert Rhythm (1540)

Patient Problems Arrhythmia (1721); Syncope/Fainting (4411)

Event Date 12/07/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced an episode of ventricular tachycardia (vt).The device appropriately identified the vt and delivered high voltage therapy, however, the shock was unable to convert the arrhythmia.The patient presented in the hospital where external defibrillation was delivered to return the patient to sinus rhythm.Abbott technical support was contacted and noted the device behaved normally according to its programmed settings.No device malfunction was alleged.The device was reprogrammed to avoid any further episodes of inadequate therapy.The patient was in stable condition.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

Event Description

Additional information received indicated the patient experience syncope due to the inadequate therapy prior to presenting in clinic.

• 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: 18318956
• MDR Text Key: 330387473
• Report Number: 2017865-2023-94672
• 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,Followup
• Report Date: 01/24/2024

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 Expiration Date: 01/31/2022
• Device Model Number: CD3367-40QC
• Device Lot Number: P000096700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2020
• 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): Other