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

Model Number 1458Q/86

Device Problem Pacing Problem (1439)

Patient Problems Arrhythmia (1721); Discomfort (2330); Heart Failure/Congestive Heart Failure (4446)

Event Date 08/11/2023

Event Type  Death  

Event Description

Related manufacture reference number: 2017865-2023-42466.Related manufacture reference number: 2017865-2023-42467.It was reported that the patient implanted an implantable cardioverter defibrillator system because of dilated cardiomyopathy on (b)(6) 2023.Post implant, it was noted in clinic that the patient experienced recurrent ventricular tachycardia.On the night of (b)(6) 2023, the patient complained of dizziness, chest distress and asthma.Rescue was not successful and the patient passed out due to congestive heart failure.The physician stated that the programmed bi-ventricular pacing rate resulted in excessive pacing causing ventricular tachycardia and ultimately accelerated heart failure.There was no allegation of device malfunction.

• 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: 17705613
• MDR Text Key: 322922700
• Report Number: 2017865-2023-42468
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458Q/86
• Device Lot Number: A000135174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• 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
• Treatment: TENDRIL LEAD
• Patient Outcome(s): Death