MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS; PERMANENT PACEMAKER ELECTRODE

Model Number 2088TC/58

Device Problems Difficult to Insert (1316); Material Twisted/Bent (2981)

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

Event Date 02/01/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented for an implant procedure.It was noted that it was difficult to insert the right ventricular lead to the introducer causing the lead to be bent.The lead was not used and replaced.The patient was stable.

Manufacturer Narrative

The reported events of difficulty getting the lead through the six french introducer could not be confirmed while lead bent was confirmed.Final analysis found that as received, a complete lead was returned with the helix retracted and clogged blood/tissue.A ring electrode measurement test was performed and the results within specification.The lead test with the introducer could not be performed due to as received lead condition.Visual examination found the helix housing separated from the ring electrode assembly and bent at the distal region consistent with procedural damage.The cause of the reported event of lead bent was isolated to the lead damaged consistent with procedural damage.

• Brand Name: TENDRIL STS
• 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: 16433885
• MDR Text Key: 310158308
• Report Number: 2017865-2023-10785
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2088TC/58
• Device Catalogue Number: 2088TC-58
• Device Lot Number: A000135014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2022
• 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
• Patient Age: 51 YR
• Patient Sex: Male