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

Model Number 1458Q/86

Device Problems Therapy Delivered to Incorrect Body Area (1508); Capturing Problem (2891)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2023

Event Type  Injury  

Event Description

It was reported that the patient with a history cardiac sarcoidosis, presented for the replacement of the left ventricular lead due to high capture threshold and phrenic nerve stimulation in all configurations.The lead was explanted.The patient was stable.

Manufacturer Narrative

The reported events were inadequate capture and extra cardiac stimulation.As received, a complete lead was returned in one piece.The reported event of inadequate capture was not confirmed.Visual and x-ray examination of the lead did not find any anomalies.Electrical tests of the lead did not find any indication of conductor fractures or internal shorts.S-curve was measured to be within specification.

Manufacturer Narrative

Correction: h3 - device evaluated by manufacturer? - was omitted from the previous report.

• 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: 18522986
• MDR Text Key: 332973545
• Report Number: 2017865-2024-01325
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: A000118336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 04/08/2024; Not provided
• Supplement Dates FDA Received: 04/18/2024; 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2021
• 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: DURATA.; GALLANT.; TENDRIL.
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 92 KG