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/46
Medical Device Problem Codes	Over-Sensing (1438); Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented remotely via merlin.Net.Upon review of the transmission, far-field r-wave (far-r) oversensing and atrial undersensing were identified.The patient subsequently presented to the emergency department for further evaluation.Upon device interrogation, ventricular non-capture was observed at maximum output in both unipolar and bipolar configurations.In addition, the atrial lead exhibited failure to sense.As a result, the pacemaker was explanted and replaced, and the atrial and right ventricular (rv) leads were capped and replaced on (b)(6) 2026.The patient was reported to be stable throughout the event and subsequent procedures.
Additional Manufacturer Narrative
Further information was requested but was not received.

• 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: 50137907
• Report Number: 2017865-2026-16383
• Device Sequence Number: 9349175
• Product Code: NVN
• UDI-Device Identifier: 05414734501743
• UDI-Public: (01)05414734501743(10)4710329(17)170731
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 08/05/2026

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: 07/31/2017
• Device Model Number: 1888TC/46
• Device Lot Number: 4710329
• 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: 07/17/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2014
• 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 Age: 78 YR
• Patient Sex: Male