MAUDE Adverse Event Report: ABBOTT TENDRIL STS; No Match

Model Number 2088TC/58

Device Problems Capturing Problem (2891); Device Sensing Problem (2917)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

During an implant procedure, a decrease in the sensing and increase in the capture threshold were observed on the right ventricular (rv) lead.The rv lead was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.

Manufacturer Narrative

The reported events of inadequate capture and r-wave amplitude variation could not be confirmed.As received, a partial distal portion of the lead was returned in one piece for analysis.Electrical testing and x-ray examination of the lead did not find any indication of conductor fractures or internal shorts.Visual inspection of the lead did not find any anomalies except for the damages found consistent with procedural damage.

• 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: 18909720
• MDR Text Key: 337728184
• Report Number: 2017865-2024-35050
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734502894
• UDI-Public: 05414734502894
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: P000176824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2023
• 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