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

Model Number 1458QL/86

Device Problems Failure to Capture (1081); Over-Sensing (1438); Device Dislodged or Dislocated (2923)

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

Event Date 02/07/2024

Event Type  Injury  

Event Description

It was reported that the patient presented remotely via merlin.Net.Upon review of the transmission, it was noted that the left ventricular lead exhibited dislodgement, loss of capture and oversensing issue.Fluoroscopy was performed and the left ventricular lead was found to be dislodged.The left ventricular lead was explanted and replaced.The patient was in stable condition throughout the procedure.

Manufacturer Narrative

The reported events were dislodgement, failure to capture, and over-sensing.As received, a complete lead was returned in one piece for analysis.The reported events of failure to capture and over-sensing were not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.A visual and x-ray inspection found no anomalies, except for procedural damage.

• 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: 18795392
• MDR Text Key: 336393954
• Report Number: 2017865-2024-33653
• Device Sequence Number: 1
• Product Code: NIK
• 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
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458QL/86
• Device Lot Number: A000143661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2023
• 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
• Treatment: DURATA STS OPTIM; GALLANT HF ICD; TENDRIL STS
• Patient Outcome(s): Required Intervention
• Patient Sex: Female