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

Model Number 2088TC/52

Device Problems Failure to Capture (1081); Under-Sensing (1661); Capturing Problem (2891); Device Dislodged or Dislocated (2923)

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

Event Date 03/09/2024

Event Type  Injury  

Event Description

It was reported that after initial implant procedure, patient's atrial lead exhibited under sensing, loss of capture, high threshold.It was further noted form x-ray that the lead was dislodged.The lead was explanted and replaced.The patient was stable.

Manufacturer Narrative

The reported events of sensing problem and capturing problem were not confirmed.A complete lead was returned.Visual examination found the helix was retracted and clogged with blood/tissue.After cleaning the helix could be extended and retracted by applying torque to the connector pin and full helix extension length was measured within specifications.Electrical testing did not find any indication of conductor fractures or internal shorts.No anomalies were noted with the exception of 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: 19006340
• MDR Text Key: 338938591
• Report Number: 2017865-2024-37263
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502887
• UDI-Public: 05414734502887
• 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
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2088TC/52
• Device Lot Number: P000193828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2024
• 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 Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female