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

Model Number	1458Q/92
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had their left ventricular (lv) lead, right ventricular (rv) lead and right atrial (ra) lead explanted due to unspecified issues.No patient condition or further information could be obtained.
Additional Manufacturer Narrative
The reported event was lead malfunction.A complete lead was returned in one piece for analysis.Visual and x-ray examinations of the lead did not find any anomalies except for procedural damage.Electrical testing did not find any indication of conductor fractures or internal shorts.Further information was requested but not received.

• 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: 21991907
• Report Number: 2017865-2025-52072
• Device Sequence Number: 8480461
• Product Code: NIK
• UDI-Device Identifier: 05414734503358
• UDI-Public: (01)05414734503358(10)A000109450(17)240430
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2025

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 Expiration Date: 04/30/2024
• Device Model Number: 1458Q/92
• Device Lot Number: A000109450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2025
• 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: 04/18/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2021
• 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: QUADRA ALLURE MPPACER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male