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 11/08/2021

Event Type  malfunction  

Event Description

It was reported that the patient presented in clinic for routine device upgrade.The left ventricular (lv) lead was placed and exhibited no capture at high threshold, failure to sense.The procedure was successfully completed with a replacement lead.The patient was stable.

Manufacturer Narrative

The reported events of failure to capture and sense were confirmed.A complete lead was returned.Electrical testing did not find any anomalies.Insertion testing of the lead connector into the icd device and is-4 sleeve passed.Dimensional analysis found the connector had an over-sized diameter.This may have contributed to the reported field events.

• 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: 12889346
• MDR Text Key: 281411189
• Report Number: 2017865-2021-37472
• 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: 02/09/2022

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: 09/30/2022
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: A000087820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 11/30/2021
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2019
• 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