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

Model Number 1458Q/86

Device Problems Separation Failure (2547); Detachment of Device or Device Component (2907)

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

Event Date 09/06/2023

Event Type  malfunction  

Manufacturer Narrative

The reported events of stylet could not be removed from lead and connector pin detachment were confirmed.As received, a complete lead was returned in one piece with the stylet stuck inside the lead.Visual inspection of the lead found that the inner coil, connector pin and crimp sleeve were pulled out of the connector assembly, consistent with procedural damage.The ptfe coating of the stylet along with the inner coil was found to have bunched up/clogged distal to the connector pin.The cause of the reported events was due to the bunched up ptfe coating of the stylet inside the inner coil that prevented the removal of the stylet and excessive forces resulted in the connector pin and crimp sleeve to be pulled out of the connector assembly.

Event Description

It was reported that the patient presented to the hospital for a scheduled implant procedure.During the procedure, while unsuccessfully attempting to separate the stylet from the left ventricular (lv) lead, it was noted that the connector pin was detached from the body of the lead.The lv lead was removed and replaced during procedure.The patient was stable throughout.

• 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: 17814868
• MDR Text Key: 324246197
• Report Number: 2017865-2023-42534
• 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
• Report Date: 09/25/2023

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: A000142752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2023
• 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: 82 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White