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

Model Number CD2357-40C

Device Problem Failure to Convert Rhythm (1540)

Patient Problem Discomfort (2330)

Event Date 12/19/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented for follow up after the implantable cardioverter delivered a shock for an episode of ventricular fibrillation.The first shock failed to convert the patient back to sinus rhythm.However the second shock at maximum energy was successful.The second shock caused the patient pain, and it was discussed that the patient had high defibrillation threshold.No interventions were made.The patient was stable.

Manufacturer Narrative

Additional information: a4.

• 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: 18478401
• MDR Text Key: 332725687
• Report Number: 2017865-2024-00792
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734508063
• UDI-Public: 05414734508063
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

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: 12/31/2018
• Device Model Number: CD2357-40C
• Device Lot Number: A000033575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2016
• 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: RIGHT VENTRICULAR LEAD; TENDRIL
• Patient Sex: Male
• Patient Weight: 104 KG