MAUDE Adverse Event Report: ABBOTT TENDRIL STS; No Match

Model Number 2088TC/46

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

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

Event Date 03/12/2024

Event Type  Injury  

Event Description

During an in-clinic follow-up, increased capture threshold was detected on the right atrial (ra) lead.An x-ray was performed and dislodgement of the ra lead was confirmed.The lead was explanted and replaced to resolve the event.The patient was stable.

• Brand Name: TENDRIL STS
• Type of Device: No Match
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19004126
• MDR Text Key: 338911006
• Report Number: 2017865-2024-37061
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502870
• UDI-Public: 05414734502870
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• 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/46
• Device Lot Number: P000145091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• 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
• Patient Outcome(s): Required Intervention