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 Break (1069)

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

Event Date 10/02/2023

Event Type  malfunction  

Event Description

It was reported that the left ventricular lead insulation was breached during implant procedure.The damaged lead was successfully exchanged.The patient was stable and asymptomatic.

Manufacturer Narrative

The reported event of insulation damage was confirmed.As received, a complete lead was returned in one piece.Visual examination found the lead body insulation was perforated/ damaged at the s-curve region consistent with guidewire damage.The cause of the reported event is consistent with procedural damage.Electrical testing did not find any indication of conductor fractures or internal shorts.

Manufacturer Narrative

Correction: investigation conclusion previously reported as 'component failure, now corrected to 'unintended user error.

• 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: 17873321
• MDR Text Key: 324976459
• Report Number: 2017865-2023-47760
• 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,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: A000131323
• 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: 10/03/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 12/20/2023; 01/02/2024
• Supplement Dates FDA Received: 12/22/2023; 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2022
• 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