MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; No Match

Model Number	1458Q
Medical Device Problem Codes	Fracture (1260); Capturing Problem (2891)
Health Effect - Clinical Code	Arrhythmia (1721)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Voluntary event report was received.Medwatch: mw5182470.
Event or Problem Description
Voluntary medwatch received states that left ventricular (lv) lead fracture was noted.The patient experienced bigeminy and the lv lead exhibited a capture issue.The physician explanted the lv lead.There were no patient consequences reported.

• Brand Name: QUARTET
• Common Device Name: No Match
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24520922
• Report Number: 2017865-2026-04613
• Device Sequence Number: 18578450
• Product Code: NIK
• UDI-Device Identifier: 05414734503334
• UDI-Public: 5414734503334
• Combination Product (Y/N): Y
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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: 1458Q
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown