MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) QUARTET; No Match

Model Number	1458QL/86
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291); Therapy Delivered to Incorrect Body Area (1508); Difficult to Remove (1528)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the implant procedure, the patient¿s left ventricular (lv) lead demonstrated failure to capture, high pacing impedance, and discomfort due to extracardiac stimulation.During a reposition attempt on (b)(6) 2026, the lv lead was found to be difficult to remove due to being stuck in the patient¿s vein.The lv lead was subsequently capped on (b)(6) 2026 and successfully replaced.The patient remained stable.

• Brand Name: QUARTET
• 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: 25527782
• Report Number: 2017865-2026-12545
• Device Sequence Number: 15861655
• Product Code: NIK
• UDI-Device Identifier: 05414734510219
• UDI-Public: (01)05414734510219(10)A000153294(17)270131
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 06/16/2026

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: 1458QL/86
• Device Lot Number: A000153294
• 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: 05/27/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2024
• 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: RIGHT VENTRICULAR LEAD
• Patient Sex: Unknown