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

Model Number 2088TC/58

Device Problems High impedance (1291); Failure to Sense (1559); Difficult to Advance (2920)

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

Event Date 11/12/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented for an implant procedure.The right ventricular (rv) lead failed to sense during the procedure and exhibited high-pacing impedance.The rv lead also had difficulty advancing after the second repositioning attempt.The rv lead was not used and replaced during the procedure.The patient was stable throughout.

Manufacturer Narrative

The reported events were difficult to advance lead, failure to sense, and high pacing impedance.As received, a complete lead was returned in one piece.The reported event of failure to sense was confirmed.X-ray examination of the lead found the inner coil in the connector region was over-torqued due to procedural damage.Electrical testing of the lead found an internal short due to the over-torqued inner coil in the connector region.The cause of the reported event of failure to sense was isolated to the over-torqued inner coil in the connector region due to procedural damage.The reported event of high-pacing impedance was not confirmed.Visual and x-ray examination of the lead found no anomalies.X-ray examination of the lead found no indication of any conductor fractures.An impedance test was unable to be performed due to the over-torqued inner coil in the connector region restricting the helix from being extended and the helix retracted with the soft tip as received.

• 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: 18254883
• MDR Text Key: 329565137
• Report Number: 2017865-2023-93737
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502894
• UDI-Public: 05414734502894
• Combination Product (y/n): Y
• Reporter Country Code: MX
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• 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: P000160039
• 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: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2022
• 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