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

Model Number CD3371-40QC

Device Problems Over-Sensing (1438); Pacing Asynchronously (1441)

Patient Problem Arrhythmia (1721)

Event Date 05/06/2023

Event Type  malfunction  

Event Description

During a remote follow up, episodes of oversensing were observed on the device.Technical support was contacted and suspected the oversensing was due to myopotentials.Additionally, technical support also observed episodes of pacemaker mediated tachycardia on the device.Technical support recommended reprogramming.No intervention has been performed at this time.The patient was stable and will continue being monitored.

• Brand Name: QUADRA ASSURA MP 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: 17845679
• MDR Text Key: 324617359
• Report Number: 2017865-2023-47370
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: CD3371-40QC
• Device Lot Number: A000102357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• 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