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

Model Number 1458Q/86

Device Problems Break (1069); Failure to Capture (1081); Contamination of Device Ingredient or Reagent (2901)

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

Event Date 05/30/2023

Event Type  malfunction  

Event Description

It was reported that during a procedure, the left ventricular lead was found to have loss of capture, insulation damage, and lead contamination.The lead was replaced and the procedure was successfully completed.No patient consequences were reported.

Manufacturer Narrative

Correction: h6: codes should reflect product not returned.

Manufacturer Narrative

Additional information: field should contain the following statement: device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

Manufacturer Narrative

The reported events were failure to capture, insulation damage and blood infiltration.A complete lead was returned in one piece.The reported event of blood infiltration was confirmed.Blood was noted throughout the lead body due to blood entering the lead body at the time of procedure which is normal.The reported events of failure to capture and insulation damage were not confirmed.Visual, x-ray and electrical evaluations were normal with no anomalies noted.S-curve was measured to be within specification.

• Brand Name: QUARTET
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17108215
• MDR Text Key: 317130211
• Report Number: 2017865-2023-22938
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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,Followup
• Report Date: 11/20/2023

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 Expiration Date: 05/31/2024
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: A000111922
• 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: 05/31/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 09/18/2023; 09/28/2023; 11/13/2023
• Supplement Dates FDA Received: 09/18/2023; 10/19/2023; 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2021
• 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