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

Model Number 2088TC/58

Device Problems Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)

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

Event Date 08/14/2023

Event Type  malfunction  

Event Description

It was reported that during implant procedure, the novel right ventricular lead failed to be fixed and the lead became dislodged.It was alleged that the lead's helix became skewed.This lead was not installed during the procedure on (b)(6) 2023.There were no patient consequences.

Manufacturer Narrative

The reported events were unable to be fixed, lead dislodged and skewed helix.As received, a complete lead was returned in one piece with the helix found extended and clogged with dried blood/tissue.The reported event of skewed helix was not confirmed.Final analysis found over torque of the inner coil at the connector region consistent with procedural damage.No further issues 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: 17662933
• MDR Text Key: 322417275
• Report Number: 2017865-2023-40763
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502894
• UDI-Public: 05414734502894
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2088TC/58
• Device Lot Number: P000170176
• 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: 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2023
• 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