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

Model Number	2088TC/46
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Therapy Delivered to Incorrect Body Area (1508); Capturing Problem (2891); Device Sensing Problem (2917)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient presented to clinic for a pacemaker check.Device interrogation revealed oversensing noise resulting in inappropriate mode switch episodes, high pacing impedance, low p-wave amplitudes, and high capture thresholds on the atrial lead.Changing from bipolar to unipolar pacing resulted in extracardiac muscle stimulation.Device was reprogrammed from dual chamber pacing and sensing (dddr) to ventricular pacing while maintaining dual chamber sensing (vddr).Patient was stable before, during, and after the check.

• Brand Name: TENDRIL STS
• Common Device Name: Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
• Manufacturer (Section D): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50898173
• Report Number: 2017865-2026-19044
• Device Sequence Number: 18819329
• Product Code: NVN
• UDI-Device Identifier: 05414734502870
• UDI-Public: (01)05414734502870(10)P000103061(17)230430
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 2088TC/46
• Device Lot Number: P000103061
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Generator, PM2272.; Lead, 2088TC/52.
• Patient Age: 70 YR
• Patient Sex: Male