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

Model Number 1458Q/86

Device Problem Failure to Disconnect (2541)

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

Event Date 07/25/2023

Event Type  malfunction  

Event Description

It was reported, during implant procedure.That the left ventricular lead could not be removed from the stylet.The lead was successfully exchanged.The patient was stable and asymptomatic.

Manufacturer Narrative

The reported event of ¿stylet became stuck within the lead¿ was confirmed.As received, a complete lead was returned in one piece with stuck guidewire inside the lead.Visual inspection found ptfe coating of the guidewire and bunched up inner coil at the connector and middle region.Unable to perform the guidewire insertion/ removal test due to the damaged inner coil.The cause of the reported event was isolated to the bunching of stripped guidewire ptfe coating and bunching of the inner coil.

• 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: 17484934
• MDR Text Key: 320853715
• Report Number: 2017865-2023-37857
• 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
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• 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: A000134099
• 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: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2022
• 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: DURATA; GALLANT; TENDRIL
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 73 KG