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

Model Number 1458QL/86

Device Problem Separation Failure (2547)

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

Event Date 01/30/2024

Event Type  malfunction  

Event Description

It was reported that the patient presented to the hospital for a scheduled implant procedure.During the procedure, the left ventricular (lv) lead had a separation failure as the stylet was stuck inside and could not be removed.The lv lead was then removed and replaced.The patient was in stable condition throughout.

Manufacturer Narrative

The reported events of stylet could not be removed was confirmed.Final analysis found that 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 connector pin and crimp sleeve were pulled out of the connector assembly along with the inner coil which is consistent with procedural damage and the ptfe stylet coating was bunched up or clogged with the inner coil distal to the connector pin.The cause of the reported event was due to 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.Electrical testing did not find any indication of conductor fractures or internal shorts.Abbott is continuing to monitor this issue.

• 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: 18728637
• MDR Text Key: 335715224
• Report Number: 2017865-2024-32949
• Device Sequence Number: 1
• Product Code: NIK
• 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: 03/01/2024

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: 1458QL/86
• Device Lot Number: A000150669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/18/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2023
• 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: 60 YR
• Patient Sex: Male