MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Quartet Lead Double Bend, 86 cm; Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

Model Number	1457Q/86
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented to the hospital for an implant procedure.During the procedure, it was noted that the left ventricular (lv) lead exhibited a high capture threshold resulting in loss of capture.Multiple attempts at different locations were made, but the issue persisted and high pacing impedance was noted.The lv lead was not used and was replaced with a left bundle branch (lbb) lead on (b)(6) 2026.The patient was discharged post-procedure.
Additional Manufacturer Narrative
Further information was requested but not received.

• Brand Name: Quartet Lead Double Bend, 86 cm
• 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: 50204708
• Report Number: 2017865-2026-16784
• Device Sequence Number: 20204221
• Product Code: OJX
• UDI-Device Identifier: 05414734510189
• UDI-Public: (01)05414734510189(10)A000174109(17)280430
• 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): 08/11/2026

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 Model Number: 1457Q/86
• Device Lot Number: A000174109
• 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: 07/23/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2025
• 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