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

Model Number 2088TC/65

Device Problem Material Twisted/Bent (2981)

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

Event Date 08/28/2023

Event Type  malfunction  

Event Description

It was reported that during initial implant procedure, patient's new right ventricular (rv) lead exhibited difficulty in advancing through patient's right ventricular septum.It was further noted that the lead was over torqued, and the lead body surface was wavy.The lead was not installed and the procedure was completed using an alternate lead on (b)(6) 2023.There were no patient consequences.

Manufacturer Narrative

The reported event of lead body over-torqued/twisted was not confirmed.As received, a complete lead with a stylet was returned in one piece for analysis.Visual inspection and x-ray examination of the lead found the helix was stretched, bent, and clogged with blood/tissue.The helix mechanism/extension length test couldn¿t perform due to the damaged helix consistent with procedural damage.Electrical testing did not find any indication of conductor fractures or internal shorts.No anomalies were found.

• 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: 17730405
• MDR Text Key: 323199563
• Report Number: 2017865-2023-42856
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734505055
• UDI-Public: 05414734505055
• 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: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2088TC/65
• Device Lot Number: P000167498
• 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: 11/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2023
• 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
• Treatment: ASSURITY; TENDRIL
• Patient Age: 66 YR