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	Failure to Advance (2524)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	07/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an upgrade procedure, the physician was unable to remove the stylet from the left ventricular (lv) lead while attempting to implant it.The lead was removed and replaced with another lead.During placement of the replacement lv lead, the physician was unable to advance the lead.An echocardiogram and contrast were performed, and cardiac perforation and pericardial effusion were identified and associated with both leads.Both leads were removed, and a port plug was placed in the lv port of the device.The patient was discharged following the surgery.

• 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: 50267062
• Report Number: 2017865-2026-17096
• Device Sequence Number: 16093071
• Product Code: OJX
• UDI-Device Identifier: 05414734510189
• UDI-Public: (01)05414734510189(10)A000182623(17)281231
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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 Model Number: 1457Q/86
• Device Lot Number: A000182623
• 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: 07/27/2026
• Initial Report FDA Received Date: 08/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2026
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Female