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 Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was remotely monitored through a merlin.Net transmission.The transmission indicated high pacing impedance measurements on the left ventricular (lv) lead.No intervention or patient condition was reported.

• 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: 50205409
• Report Number: 2017865-2026-16804
• Device Sequence Number: 5521801
• Product Code: OJX
• UDI-Device Identifier: 05414734510189
• UDI-Public: (01)05414734510189(10)A000100756(17)230831
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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 Expiration Date: 08/31/2023
• Device Model Number: 1457Q/86
• Device Lot Number: A000100756
• 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: 07/22/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2020
• 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