MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY ASSURA DR ICD, US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD2359-40QC

Device Problems Failure to Deliver Shock/Stimulation (1133); Incorrect Interpretation of Signal (1543)

Patient Problem Arrhythmia (1721)

Event Date 11/10/2022

Event Type  malfunction  

Event Description

It was reported that a patient presented in-clinic.Upon interrogation, the patient's implantable cardioverter defibrillator was found to have lost high voltage output due to inappropriate interpretation of signal.The patient had a minor arrhythmia which was terminated by the device.Corrective programming changes were made.The patient was stable throughout.

• Brand Name: FORTIFY ASSURA DR ICD, US
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 16716822
• MDR Text Key: 313155462
• Report Number: 2017865-2023-17270
• Device Sequence Number: 1
• Product Code: LWS
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: CD2359-40QC
• Device Lot Number: S000034158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2017
• 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