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

Model Number CD3367-40QC

Device Problems Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)

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

Event Date 03/20/2024

Event Type  malfunction  

Event Description

It was reported that the device was found to be in backup vvi (bvvi) mode resulting in disabled high voltage therapy.The cause of the bvvi was found to be magnetic resonance imaging (mri) exposure without enabling the mri settings.Abbott technical support was contacted and the device was successfully reprogrammed to resolve the event.The patient was in stable condition.

• 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: 19028869
• MDR Text Key: 339204659
• Report Number: 2017865-2024-37512
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508322
• UDI-Public: (01)05414734508322(10)P000124883(17)230630
• 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: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: CD3367-40QC
• Device Lot Number: P000124883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/13/2021
• 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
• Treatment: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; QUARTET; TENDRIL STS