MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD DOUBLE BEND, 86 CM; Drug eluting permanent left ventricular (lv) pacemaker electrode

Model Number 1457Q/86

Device Problems Difficult to Remove (1528); Capturing Problem (2891)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported that the patient presented in clinic for initial implant procedure.During procedure, it was found that the left ventricular (lv) lead exhibited high capture threshold and failure to remove guidewire from it.The lv was not implanted and an alternate near at hand was implanted instead on (b)(6) 2024.Patient condition was stable.

Manufacturer Narrative

The reported event of difficult to remove stylet from the lead was confirmed, but the reported event of capturing problem was not confirmed.A full lead was received in one piece for analysis.Visual examination found the inner coil damaged at 8.8, 9.7 and 13.0 cm from the connector pin, consistent with procedural damage.Due to the procedural damage of the inner coil the stylet could not be inserted.The cause of the reported event was isolated to the inner coil damaged.Electrical testing was normal with no anomalies found.

• Brand Name: QUARTET LEAD DOUBLE BEND, 86 CM
• Type of Device: Drug eluting permanent left ventricular (lv) pacemaker electrode
• 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: 18891982
• MDR Text Key: 337519622
• Report Number: 2017865-2024-34828
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734510189
• UDI-Public: 05414734510189
• Combination Product (y/n): Y
• Reporter Country Code: IN
• 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
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1457Q/86
• Device Lot Number: A000144591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• 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