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

Model Number 2088TC/52

Device Problems Break (1069); Material Twisted/Bent (2981)

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

Event Date 08/04/2023

Event Type  malfunction  

Event Description

It was reported that during initial implant procedure, patient's new implanted lead helix was damaged.It was also noted that the lead insulation was twisted.The lead was not used and the procedure was completed using ana alternate lead on (b)(6) 2023.The patient was stable.

Manufacturer Narrative

The reported events of lead twisted and the helix mechanism issue were confirmed.As received, a complete lead was returned in one piece for analysis.Visual inspection of the lead found the outer insulation twisted, and the helix was retracted and clogged with blood/tissue.X-ray examination found the over-torqued inner coil consistent with procedural damage.X-ray examination of the helix mechanism found no anomalies or distortion of the helix that would have contributed to helix mechanism issue reported in the field.Electrical testing found internal shorts between conductors due to the damaged inner coil.The cause of the reported event of helix mechanism issue was isolated to the over-torqued inner coil and the helix being clogged with blood/tissue.No other 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: 17638426
• MDR Text Key: 322180066
• Report Number: 2017865-2023-40504
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502887
• UDI-Public: 05414734502887
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• 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: P000157601
• 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: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2022
• 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