MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKFLEX MICRO LV LEAD; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 1258T/86

Device Problems Failure to Advance (2524); Capturing Problem (2891)

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

Event Date 09/25/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented for an implant procedure.During the procedure, it was noted that the left ventricular (lv) lead exhibited high capture threshold measurements and the guidewire was unable to be advanced into the lead.The lead was not used, and a new lead was implanted.The patient was stable throughout the procedure.

Manufacturer Narrative

The reported events were high capture threshold and ¿guidewire was unable to be advanced into the lead¿.As received, a complete lead was returned.The reported event of high capture threshold was not confirmed.Electrical testing and x-ray examination were normal except for procedural damage.The reported event of ¿guidewire was unable to be advanced into the lead¿ was confirmed.A guidewire insertion test was unable to be performed due to the condition of the inner coil.Visual inspection found the inner coil to be kinked with pieces of ptfe coating of the guidewire at the middle region of the lead.The cause of ¿guidewire was unable to be advanced into the lead¿ was due to the inner coil being damaged and ptfe coating from the guidewire consistent with occurring at the time of procedural.

• Brand Name: QUICKFLEX MICRO LV LEAD
• 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: 17931961
• MDR Text Key: 325625796
• Report Number: 2017865-2023-47685
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734502610
• UDI-Public: 05414734502610
• 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,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1258T/86
• Device Lot Number: A000138516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2023
• 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