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

Model Number 1258T/86

Device Problems Capturing Problem (2891); Device Sensing Problem (2917)

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

Event Date 09/26/2022

Event Type  malfunction  

Manufacturer Narrative

Further information was requested but not received.

Event Description

It was reported that the patient presented to the hospital for a scheduled implant procedure.During the procedure, the left ventricular (lv) lead exhibited sensing problems.The lv lead was then removed and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported event of unable to get acceptable pacing threshold was not confirmed.Final analysis found that as received, a complete lead was returned in one piece.Electrical testing did not find any indication of conductor fractures or internal shorts.The s-curve height was measured within specification.Visual and x-ray examinations did not find any anomalies except for procedural damage.No other anomalies were seen.

Event Description

New information received notes that the left ventricular (lv) lead exhibited unacceptable pacing threshold measurements which was originally submitted in mfr 2017865-2023-02329.

• Brand Name: QUICKFLEX MICRO LV LEAD
• Type of Device: PERMANENT 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15613133
• MDR Text Key: 306278545
• Report Number: 2017865-2022-41884
• 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,Followup,Followup,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 1258T/86
• Device Catalogue Number: 1258T-86
• Device Lot Number: A000079844
• 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: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2019
• 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