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

Model Number 2088TC/58

Device Problems Difficult to Fold, Unfold or Collapse (1254); Material Twisted/Bent (2981)

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

Event Date 09/25/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented for routine implant of the right ventricular lead.During the procedure the physician felt resistance when extending the helix.The helix was then retracted and removed from the body.Visual inspection showed that the lead insulation had become twisted, and tissue was lodged in the helix tip.A replacement lead was ultimately used to complete the procedure.The patient was stable.

Manufacturer Narrative

The reported events of helix mechanism issue and insulation twisted were confirmed.As received, a complete lead was returned in one piece with the helix found extended and clogged with dried tissue.X-ray inspection found overtorque of the inner coil at the connector region, consistent with procedural damage.X-ray examination of the helix mechanism found no anomalies or distortion of the helix that would have contributed to helix mechanism issue reported in the field.The cause of the reported events of helix mechanism issue was isolated to tissue in the helix and overtorque of the inner coil which caused the twisted insulation.Electrical testing did not find any indication of conductor fractures or internal shorts.

• Brand Name: TENDRIL STS
• 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: 17948327
• MDR Text Key: 325807714
• Report Number: 2017865-2023-49882
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502894
• UDI-Public: 05414734502894
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P960013
• 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: 11/06/2023

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: 2088TC/58
• Device Lot Number: A000146890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 10/20/2023
• Supplement Dates FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2023
• 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 Sex: Female