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

Model Number 1458Q/86

Device Problems Failure to Capture (1081); Failure to Sense (1559)

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

Event Date 11/18/2021

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2021-37514.It was reported that patient presented during implant procedure.Upon interrogation, it was noted that the left ventricular lead (lv lead) failed to capture and failed to sense while the right ventricular lead (rv lead) exhibited high capture threshold and high pacing impedance.The procedure was completed by replacing both rv and lv leads with alternative leads at the respective positions on (b)(6) 2021.The patient was in stable condition.

Manufacturer Narrative

The reported events of capture and sensing problem were not confirmed.As received, a complete lead was returned for evaluation.Electrical tests, insertion testing, and dimensional analysis did not identify any anomalies.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12865877
• MDR Text Key: 281198441
• Report Number: 2017865-2021-37515
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 01/25/2022

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: A000110934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 01/10/2022
• Supplement Dates FDA Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2021
• 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