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

Model Number CD3371-40QC

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)

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

Event Date 02/16/2024

Event Type  Injury  

Event Description

It was reported that the device entered backup mode following a magnetic resonance imaging (mri) scan.The device was not reprogrammed into mri mode prior to mri exposure.While the device was in backup mode, it delivered inappropriate defibrillation therapy due to supraventricular tachycardia.No allegation of malfunction was made against the device and the physician alleged the device worked as expected based upon the programmed settings.Abbott technical support was contacted and the device was restored and reprogrammed to resolve the event.The patient was in stable condition.

• 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: 18991960
• MDR Text Key: 338874685
• Report Number: 2017865-2024-35091
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: CD3371-40QC
• Device Lot Number: A000025192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2016
• 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