MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; NO MATCH

Model Number 1458Q/86

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope/Fainting (4411); Embolism/Embolus (4438)

Event Date 11/21/2023

Event Type  Death  

Event Description

Related manufacturer reference numbers: 2017865-2023-94481, related manufacturer reference numbers: 2017865-2023-94483, related manufacturer reference numbers: 2017865-2023-94484, related manufacturer reference numbers: 2017865-2023-94485, related manufacturer reference numbers: 2017865-2023-94486.It was reported that the patient presented in clinic for initial implant procedure.During procedure, it was found that the newly placed right atrial (ra) exhibited high capture threshold and high pacing impedance and the newly placed implantable cardioverter defibrillator (icd) exhibited failure to pace.The ra lead and the icd were not implanted and alternates near at hand were implanted instead on (b)(6) 2023 to complete the procedure.Post procedure, the patient went into a coma and eventually passed away due to acute pulmonary embolism.

Manufacturer Narrative

Correction: h6 - type of investigation.

• Brand Name: QUARTET
• 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: 18307499
• MDR Text Key: 330220466
• Report Number: 2017865-2023-94487
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1458Q/86
• Device Lot Number: A000137068
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2023
• 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
• Patient Outcome(s): Death