MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY QUADRA CRT-D, US MODEL, DF4COMP; NO MATCH

Model Number	CD3249-40Q
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented in clinic for implantable cardioverter defibrillator (icd) and left ventricular (lv) lead implant procedure.During procedure, it was noted that the guidewire failed to be withdrawn from the lv lead and that the lv lead became fractured from tension.It was also found that the set screw of the right ventricular port of the icd failed to be tightened and the header of the icd failed to accept the connection to the lead.The icd and lv lead were not implanted, and a replacement icd and lv lead were implanted on (b)(6) 2025.The patient was stable throughout.

• Brand Name: UNIFY QUADRA CRT-D, US MODEL, DF4COMP
• 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: 24163865
• Report Number: 2017865-2026-01540
• Device Sequence Number: 18539311
• Product Code: NIK
• UDI-Device Identifier: 05414734504546
• UDI-Public: (01)05414734504546(10)A000165266(17)260331
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2026

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: 03/31/2026
• Device Model Number: CD3249-40Q
• Device Catalogue Number: CD3249-40Q
• Device Lot Number: A000165266
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 03/31/2026; 06/16/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 03/31/2026; 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2024
• 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