MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT HF; No Match

Model Number CDHFA500Q

Device Problem Failure to Convert Rhythm (1540)

Patient Problem Arrhythmia (1721)

Event Date 07/27/2023

Event Type  Death  

Event Description

It was reported that the patient presented remotely via merlin.Net.Upon review of transmission, it was found that the implantable cardioverter defibrillator exhibited inadequate high voltage therapy for a ventricular fibrillation and the patient was still in the lower rate arrhythmia after the therapy.It was then suspected that the patient had likely passed away.Further information regarding cause of death was requested but not received.

• Brand Name: GALLANT HF
• 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: 17570149
• MDR Text Key: 321400175
• Report Number: 2017865-2023-38624
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032010
• UDI-Public: 05415067032010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• 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
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: CDHFA500Q
• Device Lot Number: S000084952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• 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
• Treatment: OPTISURE LEADS.; QUARTET LEADS.; TENDRIL LEADS.
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Sex: Male