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

Model Number 2088TC/46

Device Problems Capturing Problem (2891); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)

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

Event Type  Injury  

Event Description

It was reported that a patient presented to clinic for follow up.Device interrogation revealed high capture threshold and low p-waves on the atrial lead.Chest x-ray was performed and revealed atrial lead dislodgement.The physician elected to explant and replace the atrial lead.The patient condition was stable.

Manufacturer Narrative

The reported events were lead dislodgement, unacceptable threshold, and p-wave amp variation.Visual examination of the lead found the helix was extended and clogged with blood / tissue.After cleaning and applying torque directly to the connector pin, the helix could be retracted and extended.The full helix extension length was measured within specification.The reported events unacceptable threshold and p-wave amp variation were not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual and x-ray inspections of the lead did not find any anomalies except for 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: 18913638
• MDR Text Key: 337776647
• Report Number: 2017865-2024-35094
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502870
• UDI-Public: 05414734502870
• 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,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 2088TC/46
• Device Lot Number: P000101411
• 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: 02/26/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2020
• 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 PM; TENDRIL RV LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male