MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD SMALL-S, 86 CM; NO MATCH

Model Number 1456Q/86

Device Problems Break (1069); Separation Failure (2547); Device Dislodged or Dislocated (2923)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

It was reported that during an implant procedure, the left ventricular (lv) lead dislodged.When the lv lead was repositioned, the stylet was found to be stuck in the lead.With additional force, the stylet was able to be removed.Another lv lead was successfully implanted.The patient was in stable condition.

Manufacturer Narrative

The reported events were lead dislodgement, stylet could not be removed and lead damaged.Final analysis found a complete lead was returned in one piece with the stylet stuck inside the lead.The reported events of stylet could not be removed and lead damaged were confirmed.Visual inspection of the lead found that the connector pin and connector cap 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/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 that prevented the removal of the stylet and excessive forces resulted in the connector pin and cap to be pulled out of the connector assembly.The full measured s-curve hump height was within specification.Electrical testing did not find any indication of conductor fractures or internal shorts.A review of the device history record (dhr) confirmed that no issues were identified related to this reported event.

• Brand Name: QUARTET LEAD SMALL-S, 86 CM
• 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: 18403694
• MDR Text Key: 331494046
• Report Number: 2017865-2023-95657
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510158
• UDI-Public: 05414734510158
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

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: 1456Q/86
• Device Lot Number: A000132705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 02/05/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2022
• 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