MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY ASSURA DR ICD, US; Pulse generator, permanent, implantable

Model Number CD2357-40Q

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

Patient Problem Dyspnea (1816)

Event Date 12/04/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented to the clinic with shortness of breath.Remote transmission showed the device was in backup vvi mode.It was noted that the patient had an mri.Device interrogation confirmed the backup mode.A device restoration was performed successfully, and the device was reprogrammed to previous programmed settings.

• Brand Name: FORTIFY ASSURA DR ICD, US
• Type of Device: Pulse generator, permanent, implantable
• 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: 18372537
• MDR Text Key: 331103726
• Report Number: 2017865-2023-95308
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734508094
• UDI-Public: 05414734508094
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2023

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: 08/31/2022
• Device Model Number: CD2357-40Q
• Device Lot Number: A000100191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2020
• 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
• Treatment: DURATA; TENDRIL
• Patient Sex: Male