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 Problem Failure to Advance (2524)

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

Event Date 08/10/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented for an implant procedure.During the procedure, the guidewire failed to advance through the left ventricular (lv) lead.The lead was not used, and a new lead was implanted.The patient was stable throughout the procedure.

Manufacturer Narrative

The reported event of failure to advance guidewire was not confirmed.As received, a complete lead was returned.Visual and x-ray examination as well as electrical testing were normal.A guidewire was able to be fully inserted and removed from the inner coil with no obstruction/restriction.

• 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: 17592094
• MDR Text Key: 321693892
• Report Number: 2017865-2023-38615
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• 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: 10/13/2023
• 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