MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) TENDRIL ST; NO MATCH

Model Number	1882TC/52
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for a follow-up visit in the clinic.The transmissions showed that the right atrial (ra) lead exhibited noise oversensing, which resulted in pacing inhibition and episodes of inappropriate mode switching.Programming changes were made.The ra lead was connected to the new pacemaker during the device downgrade procedure on (b)(6) 2026.The patient remained in stable condition before, during, and after the procedure.
Additional Manufacturer Narrative
Correction: the correct usi number should have been (b)(4), rather than (b)(4).The correct event description in b5 should have been "it was reported that the patient presented for a follow up visit in the clinic.The transmissions showed that the right atrial (ra) lead exhibited noise oversensing, which resulted in pacing inhibition and episodes of inappropriate mode switching.During the device downgrade procedure on (b)(6) 2026.The ra lead was connected to the new pacemaker and programming changes were made.The patient remained in stable condition before, during, and after the procedure.", rather than "it was reported that the patient presented for a follow-up visit in the clinic.The transmissions showed that the right atrial (ra) lead exhibited noise oversensing, which resulted in pacing inhibition and episodes of inappropriate mode switching.Programming changes were made.The ra lead was connected to the new pacemaker during the device downgrade procedure on (b)(6) 2026.The patient remained in stable condition before, during, and after the procedure.".
Event or Problem Description
It was reported that the patient presented for a follow up visit in the clinic.The transmissions showed that the right atrial (ra) lead exhibited noise oversensing, which resulted in pacing inhibition and episodes of inappropriate mode switching.During the device downgrade procedure on (b)(6) 2026.The ra lead was connected to the new pacemaker and programming changes were made.The patient remained in stable condition before, during, and after the procedure.

• Brand Name: TENDRIL ST
• Common Device Name: NO MATCH
• 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: 24762584
• Report Number: 2017865-2026-06794
• Device Sequence Number: 10157243
• Product Code: NVN
• UDI-Device Identifier: 05414734501699
• UDI-Public: (01)05414734501699(10)3197887(17)130930
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: 09/30/2013
• Device Model Number: 1882TC/52
• Device Lot Number: 3197887
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2010
• 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: DURATA LEAD.; FORTIFYASSURA DR ICD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male