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 03/25/2024

Event Type  malfunction  

Event Description

It was reported that the patient presented in clinic due to muscle stimulation.Device interrogation revealed that off label use was noted prior to magnetic resonance imaging test proper procedure was not followed and device went into back up mode and loss back up defibrillation therapy on the implantable cardioverter defibrillator (icd).Programming changes were performed to resolve the issue.The patient was in stable condition.

• 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: 19093697
• MDR Text Key: 340581422
• Report Number: 2017865-2024-38252
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508407
• UDI-Public: (01)05414734508407(10)P000131859(17)230930
• Combination Product (y/n): N
• Reporter Country Code: UP
• 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: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: CD3371-40QC
• Device Lot Number: P000131859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2021
• 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