MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; No Match

Model Number CD3371-40QC

Device Problems Therapy Delivered to Incorrect Body Area (1508); Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)

Patient Problem Discomfort (2330)

Event Date 04/03/2024

Event Type  malfunction  

Event Description

It was reported that a patient presented to the emergency room feeling stimulation from their implantable cardiac defibrillator (icd).Device interrogation revealed that the icd was in backup mode due to off-label mri use and high voltage therapies were inactive.The icd was restored back to normal settings.There were no patient consequences.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: No Match
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19144688
• MDR Text Key: 340873145
• Report Number: 2017865-2024-39144
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508407
• UDI-Public: (01)05414734508407(10)A000117799(17)231130
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2024

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: 11/30/2023
• Device Model Number: CD3371-40QC
• Device Lot Number: A000117799
• 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: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2021
• 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