MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) QUARTET LEAD SMALL-S, 86 CM; No Match

Model Number	1456Q/86
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Further information was requested but not received.
Event or Problem Description
It was reported that the patient presented for a cardiac resynchronization therapy defibrillator (crt-d) implant procedure.During the procedure, the low voltage lead was noted to have a faulty probe.Additionally, the left ventricular (lv) lead was reported to be contaminated.The left bundle branch pacing (lbbp) lead implantation was also cancelled for unknown reasons.All three leads were not used and were subsequently replaced.The patient¿s condition was unknown.

• Brand Name: QUARTET LEAD SMALL-S, 86 CM
• 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: 25452119
• Report Number: 2017865-2026-12017
• Device Sequence Number: 18319977
• Product Code: NIK
• UDI-Device Identifier: 05414734510158
• UDI-Public: (01)05414734510158(10)A000164909(17)270930
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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): 06/10/2026

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: 1456Q/86
• Device Lot Number: A000164909
• 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: 05/25/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2024
• 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
• Patient Sex: Unknown