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

Model Number 2088TC/52

Device Problems Retraction Problem (1536); Capturing Problem (2891); Device Sensing Problem (2917)

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

Event Date 03/26/2024

Event Type  malfunction  

Event Description

It was reported that the patient presented for an implant procedure.During the procedure, it was noted that the right atrial lead (ra) exhibited a high capture threshold and low atrial sensing issue.While attempting to change positions, the helix of the ra lead exhibited difficulty in retracting.Additionally, the right ventricular lead (rv) was found to have a helix retraction issue and a crystalline object fell out of the lead.The ra and rv leads were not used and replaced during the procedure.The patient experienced no consequences.

Manufacturer Narrative

The reported events were failure to retract helix, high capture thresholds and low sensing.As received, a complete lead was returned in one piece with the helix found bent due to procedural damage and clogged with blood.The reported event of helix mechanism issue was confirmed.X-ray inspection found over-torque of the inner coil at the connector region consistent with procedural damage.X-ray examination of the helix mechanism found the helix bent consistent with procedural damage.The cause of the reported event of failure to retract helix was isolated to helix bent and over-torqued of the inner coil.The reported events of high capture thresholds and low sensing were not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual and x-ray inspections of the lead did not find any anomalies except for procedural damage.

• 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: 19133298
• MDR Text Key: 341026569
• Report Number: 2017865-2024-39016
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502887
• UDI-Public: (01)05414734502887(10)P000183186(17)260930
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P960013
• 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
• Report Date: 04/18/2024

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: 2088TC/52
• Device Lot Number: P000183186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/11/2023
• 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