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

Model Number 1458Q/86

Device Problems Break (1069); Failure to Capture (1081); Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

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

Event Date 08/28/2023

Event Type  malfunction  

Event Description

It was reported during implant procedure that the left ventricular lead exhibited loss of capture and had dislodged.Attempt to advance a guidewire over the lead was unsuccessful.A stylet was then used to advance the lead, but in attempting to remove said stylet it became stuck in the lead.Upon stylet removal, the inner conductor came out with the stylet.The broken lead was successfully exchanged.The patient was stable and asymptomatic.

Manufacturer Narrative

The reported events were lead dislodgement, failure to capture, difficulty inserting a stylet, stylet could not be removed and lead damage.The reported events of difficulty inserting a stylet, stylet could not be removed, and lead damage were confirmed but the reported event of failure to capture was not confirmed.As received, a complete lead with stylet stuck was returned in one piece.The ptfe coating of the stuck stylet was stripped and was found bunched up with the inner coil distal to the connector pin.The connector pin with the cap and crimp sleeve were found pulled out of the molded connector consistent with damage due to excessive forces applied while attempting to remove the stylet from the lead during the procedure.The cause of the reported events of difficulty inserting a stylet, stylet could not be removed, and lead damage was isolated to the bunching of the stylet ptfe coating inside the inner coil at the connector region that prevented the removal of the stylet and excessive forces resulted in the connector pin to be pulled out through the connector assembly.Electrical testing did not find any indication of conductor fractures or internal shorts.The s-curve height was measured within specification.

• 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: 17726095
• MDR Text Key: 323321068
• Report Number: 2017865-2023-42760
• 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: 10/04/2023

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: A000134865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2022
• 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
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 113 KG