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

Model Number 2088TC/65

Device Problems Fracture (1260); Material Twisted/Bent (2981)

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

Event Date 09/27/2023

Event Type  malfunction  

Event Description

It was reported that during implant procedure fractured and abnormal curve was noted on patient's new right ventricular (rv) lead.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 curved was confirmed.The reported event of lead fracture was not confirmed.As received, a complete lead was returned in one piece with helix found stretched/bend with traces of blood/body fluid.Visual inspection of the lead found the lead body was stretched and the helix housing was pulled from the distal boot with the inner coil found stretched.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual and x-ray examinations did not find any anomalies except for procedural damage.The cause of the reported event is consistent with 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: 17936000
• MDR Text Key: 325681605
• Report Number: 2017865-2023-49654
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734505055
• UDI-Public: 05414734505055
• Combination Product (y/n): Y
• Reporter Country Code: TH
• 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: 11/20/2023

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/65
• Device Lot Number: P000147256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 11/14/2023
• Supplement Dates FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• 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