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

Model Number	1458Q/75
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented to the hospital for a scheduled implant procedure.During the procedure, the quadripolar left ventricular (lv) lead failed to advance through the sub-selector catheter.The lv lead was removed and replaced.The patient was in stable condition.
Additional Manufacturer Narrative
The reported events of ¿lead didn't have enough length to fully come out of the subselector cps aim universal ds2n027-65¿ and ¿not all rings of the electrode were able to get outside of the catheter¿ was not confirmed.As received, a complete lead without the subselector cps aim universal ds2n027-65 was returned in one piece for analysis.The lead could be fully inserted inside the catheter and removed without difficulties using a correct length of catheter.An incompatible catheter was used during the procedure.Visual and x-ray inspections of the lead did not find any anomalies.

• 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: 23812836
• Report Number: 2017865-2025-1007359
• Device Sequence Number: 15774453
• Product Code: NIK
• UDI-Device Identifier: 05414734503334
• UDI-Public: (01)05414734503334(10)A000159799(17)270630
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: 1458Q/75
• Device Lot Number: A000159799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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