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

Model Number	1888TC/52
Medical Device Problem Codes	Break (1069); Low impedance (2285); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented remotely via merlin.Net.Review of the transmission revealed that the right ventricular (rv) lead exhibited low pacing impedance in bipolar configurations, which had been observed for at least the previous year.The patient subsequently presented for a generator change procedure, during which pre-procedure interrogation confirmed low pacing impedance and decreased r-wave amplitudes on the rv lead.During the procedure, it was revealed that the outer insulation of the rv lead was missing from the end of the yoke to approximately 7 mm distal.The insulation damage was visually confirmed.The rv lead was repaired and remained implanted, electrical testing remained unchanged.The patient remained in a stable condition throughout the procedure.
Additional Manufacturer Narrative
Section b3: the reported event date is an estimate.The event date was reported as follow, ¿rv impendence has been around 230 for at least the past year according to trend on merlin.Net¿.

• Brand Name: TENDRIL ST
• 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: 50942668
• Report Number: 2017865-2026-20695
• Device Sequence Number: 9589257
• Product Code: NVN
• UDI-Device Identifier: 05414734501750
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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): 09/30/2026

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 Expiration Date: 03/30/2010
• Device Model Number: 1888TC/52
• Device Lot Number: 0002130650
• 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: 09/16/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Assurity.; Tendril SDX.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male