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

Model Number 1458Q/86

Device Problem Failure to Advance (2524)

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

Event Date 10/04/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented for implant procedure.During the procedure, the left ventricular (lv) lead failed to advance through the guidewire.The lv lead was not used and replaced during the procedure.The patient was stable throughout.

Manufacturer Narrative

The reported event of failure to advance lead in the catheter was not confirmed.As received, a complete lead was returned in one piece without the catheter.The catheter insertion test was performed, and the lead could be inserted inside the catheter and removed easily.Electrical testing found no any indication of conductor fractures or internal shorts.Visual and x-ray examinations of the lead did not find any anomalies.

Manufacturer Narrative

Correction for h2 section in mdr.Supposedly need to check for correction box instead of additional information and device evaluation boxes.

Manufacturer Narrative

The reported event of failure to advance guidewire to the lead was not confirmed.As received, a complete lead was returned in one piece.The guidewire used in the field was not returned with the lead for analysis.The guidewire insertion test was performed, and the guidewire could be inserted inside the lead and removed without difficulties.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual and x-ray examinations of the lead did not find any 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: 17993610
• MDR Text Key: 326349102
• Report Number: 2017865-2023-50453
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• 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: A000142553
• 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: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2023
• 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
• Patient Age: 83 YR
• Patient Sex: Female