MAUDE Adverse Event Report: ABBOTT TENDRIL STS; No Match

Model Number 2088TC/52

Device Problems High impedance (1291); Capturing Problem (2891); Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)

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

Event Date 03/11/2024

Event Type  Injury  

Event Description

It was reported that high pacing impedance and high capture threshold was observed on the right atrial (ra) lead.Upon investigation, the ra lead was observed to be dislodged via an x-ray.The lead was explanted and replaced to resolve the event and the patient was in stable condition.The lead was inspected during the lead replacement procedure and the insulation was noted to be twisted.

• 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: 18980717
• MDR Text Key: 338625762
• Report Number: 2017865-2024-36924
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502887
• UDI-Public: 05414734502887
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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: P000186826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2023
• 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