MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; NO MATCH

Model Number 1458Q/86

Device Problems Failure to Capture (1081); Therapy Delivered to Incorrect Body Area (1508); Use of Device Problem (1670); Difficult to Advance (2920)

Patient Problem Discomfort (2330)

Event Date 10/12/2023

Event Type  malfunction  

Event Description

It was reported that during an implant procedure that the left ventricular (lv) lead had no capture and there was phrenic nerve stimulation.It was also noted that the physician had difficulty inserting the guidewire and maneuvering the lv lead.The lv lead was not used and the physician elected to complete the procedure with a different lv lead.The patient condition was stable.

Manufacturer Narrative

The reported events were failure to capture, guidewire could not be inserted, operation issue and extra cardiac stimulation.The reported events of failure to capture and guidewire could not be inserted were not confirmed.Electrical testing and x-ray examination of the lead did not find any indication of conductor fractures or internal shorts.Visual inspection of the lead did not find any anomalies.The lead was tested with a guidewire and was able to be inserted from the connector pin and out to the distal tip and was able to be removed with no anomalies.

• Brand Name: QUARTET
• Type of Device: NO MATCH
• 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: 18076701
• MDR Text Key: 327437162
• Report Number: 2017865-2023-51738
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• 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
• Report Date: 01/17/2024

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: 1458Q/86
• Device Lot Number: A000141051
• 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: 10/18/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2023
• 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