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

Model Number	1456Q/86
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during implant procedure that the left ventricular lead could not be fixated.During the operation, the patient suffered heart failure symptoms and the procedure was rescheduled for a later date.There was no allegation that the heart failure was caused by the lead.The patient was stable following procedure.

• 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: 25602838
• Report Number: 2017865-2026-13017
• Device Sequence Number: 20184913
• Product Code: NIK
• UDI-Device Identifier: 05414734510158
• UDI-Public: (01)05414734510158(10)A000144658(17)260630
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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): 06/23/2026

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: 06/30/2026
• Device Model Number: 1456Q/86
• Device Lot Number: A000144658
• 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: 06/02/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2023
• 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