MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD DOUBLE BEND, 86 CM; PERMANENT PACEMAKER ELECTRODE

Model Number 1457Q/86

Device Problem Separation Failure (2547)

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

Event Date 02/15/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented for an implant procedure.During the procedure, it was noted that the left ventricular (lv) lead exhibited separation failure issue.The lv lead was not used and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported event of guidewire stuck inside lead was confirmed.As received, a complete lead with stuck guidewire was returned in one piece.The ptfe coating of the stuck guidewire 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 stretching the inner coil consistent with damage due to excessive forces applied while attempting to remove the guidewire from the lead during the procedure.The cause of the reported event was isolated to the bunching of the guidewire ptfe coating inside the inner coil at the connector region that prevented the removal of the guidewire and excessive forces resulted in the connector pin with the cap and crimp sleeve to be pulled out through the connector assembly.A review of the device history record (dhr) confirmed that no issues were identified related to this reported event.

• Brand Name: QUARTET LEAD DOUBLE BEND, 86 CM
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: 16492775
• MDR Text Key: 310786000
• Report Number: 2017865-2023-11982
• Device Sequence Number: 1
• Product Code: OJX
• 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: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1457Q/86
• Device Catalogue Number: 1457Q/86
• Device Lot Number: A000133392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2022
• 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: ASSURITY MRI PACEMAKER; TENDRIL LEAD; TENDRIL LEAD
• Patient Sex: Male