MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY ASSURA DR ICD, US; Implantable cardioverter defibrillator (non-CRT)

Model Number CD2359-40QC

Device Problem Over-Sensing (1438)

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

Event Date 04/03/2024

Event Type  malfunction  

Event Description

It was reported that a patient presented with post-paced t-wave oversensing on the implantable cardioverter defibrillator (icd).Programming changes were made to resolve the issue.The patient condition was stable before, during, and after.

• Brand Name: FORTIFY ASSURA DR ICD, US
• Type of Device: Implantable cardioverter defibrillator (non-CRT)
• 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: 19164547
• MDR Text Key: 341000143
• Report Number: 2017865-2024-39387
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734508124
• UDI-Public: (01)05414734508124(10)A000119767(17)231231
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: CD2359-40QC
• Device Lot Number: A000119767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/11/2022
• 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