MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) QUICKFLEX MICRO LV LEAD; Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

Model Number	1258T/86
Medical Device Problem Codes	Failure to Capture (1081); Therapy Delivered to Incorrect Body Area (1508); Under-Sensing (1661)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for an implant procedure.During the procedure, it was noted that the left ventricular lead exhibited a low r-wave amplitude, resulting in under-sensing.The lead also exhibited a high capture threshold with phrenic nerve stimulation, resulting in patient discomfort.The high capture threshold subsequently resulted in loss of capture.The lead was not used, and the procedure was completed with a conventional dual-chamber implantable cardioverter defibrillator (dicd) implantation.The patient was discharged.

• Brand Name: QUICKFLEX MICRO LV LEAD
• Common Device Name: Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
• 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: 50468466
• Report Number: 2017865-2026-18022
• Device Sequence Number: 16018354
• Product Code: OJX
• UDI-Device Identifier: 05414734502610
• UDI-Public: (01)05414734502610(10)A000149574(17)260930
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 09/30/2026
• Device Model Number: 1258T/86
• Device Lot Number: A000149574
• 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: 08/11/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• 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
• Patient Sex: Unknown