MAUDE Adverse Event Report: Abbott TENDRIL STS; Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

Model Number	2088TC/65
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that episodes of noise were observed on the right ventricular (rv) lead.During a surgical procedure, it was observed the stylet was unable to be inserted into the rv lead.The rv lead was explanted and replaced to resolve event.The patient was stable.

• Brand Name: TENDRIL STS
• Common Device Name: Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
• Manufacturer (Section D): Abbott; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): Abbott Medical; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50372314
• Report Number: 2017865-2026-17645
• Device Sequence Number: 9818374
• Product Code: NVN
• UDI-Device Identifier: 05414734505055
• UDI-Public: (01)05414734505055(10)P000186825(17)261031
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/21/2026

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
• Operator of Device: Health Professional
• Device Model Number: 2088TC/65
• Device Lot Number: P000186825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown