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

Model Number 1458Q/86

Device Problems Break (1069); Failure to Disconnect (2541); Separation Failure (2547)

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

Event Type  malfunction  

Event Description

It was reported that during implant catheter was stuck on a lead and was difficult to remove on the left ventricular (lv) lead.The physician elected to replace the lv lead.There were no patient consequences.

Event Description

New information notes that the insulation damage was caused by the catheter.

Event Description

It was reported that during implant catheter was stuck on a lead and was difficult to remove causing insualtion break on the left ventricular (lv) lead.The physician elected to replace the lv lead.There were no patient consequences.

Manufacturer Narrative

The reported events of lead was ¿really tight¿ inside of the inner catheter, and due to the excess resistance from the valve the insulation on the lead was cut were confirmed.As received a complete lead was returned in one piece.The cause of the reported events was the slitting technique used during the procedure.Electrical, mechanical, and visual analysis was normal with no anomalies found.

• 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: 18000484
• MDR Text Key: 326449693
• Report Number: 2017865-2023-50578
• 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: 01/19/2024

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: A000143541
• 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: 10/24/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 10/24/2023; 11/17/2023; 01/10/2024
• Supplement Dates FDA Received: 10/25/2023; 11/28/2023; 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2023
• 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
• Treatment: 2088TC/52; 7122Q/65; CDHFA500Q
• Patient Age: 75 YR
• Patient Sex: Male