MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE CRT-P; NO MATCH

Model Number	PM3140
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an implant procedure, the atrial lead could not be connected to the pacemaker (pm).The physician elected to not used the pm.Finally, the same atrial lead was connected to the new pm successfully.The patient was stable throughout the procedure.
Additional Manufacturer Narrative
Analysis conclusion received was not reported previously at manufacturer narrative.Hence, the analysis conclusion was updated as below.Manufacturer narrative: the reported event of could not connect the atrial lead in the header was not confirmed.Analysis revealed no lead insertion problems were found.Is-1 leads fully inserted into the a-connector.All lead insertion tests, and connector bore tests passed and were in specification.Leads inserted normally into the connectors and the setscrews tightened down on the leads holding them firmly in the connectors.No device anomalies were found.The device is normal.
Additional Manufacturer Narrative
Correction: related report numbers was updated for missing in mdr-2025-40517-02.

• Brand Name: QUADRA ALLURE CRT-P
• 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: 23070240
• Report Number: 2017865-2025-28256
• Device Sequence Number: 18658066
• Product Code: NIK
• UDI-Device Identifier: 05414734507899
• UDI-Public: (01)05414734507899(10)P000193484(17)250831
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030035
• 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,Followup
• Report Date (Section B): 03/19/2026

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: 08/31/2025
• Device Model Number: PM3140
• Device Lot Number: P000193484
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 02/24/2026; 03/06/2026; 03/06/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 02/26/2026; 03/06/2026; 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2024
• 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