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

Model Number	PM3140
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for routine implant of the pulse generator.During the procedure the physician attempted to connect the generator to a lead with a torque wrench.However, the wrench was unable to engage the set screw.The procedure was completed with use of a replacement device.The patient was stable.
Additional Manufacturer Narrative
The reported event of atrial setscrew could not be tightened was confirmed.Analysis revealed that the user/surgeon had stripped the atrial setscrew due to incorrect and partial wrench insertion into the setscrew inset.This prevented the setscrew from tightening down on the lead.Lab testing found that all of the setscrews (right atrial (ra)-, left ventricular and right ventricular (rv)) could be fully tightened with the wrench clicking when the wrench was fully and correctly inserted into the setscrews.This problem is related to the incorrect use of the torque wrench.

• 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: 21628277
• Report Number: 2017865-2025-27720
• Device Sequence Number: 13020504
• Product Code: NIK
• UDI-Device Identifier: 05414734507899
• UDI-Public: (01)05414734507899(10)P000177741(17)250228
• 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
• Report Date (Section B): 05/08/2025

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: 02/28/2025
• Device Model Number: PM3140
• Device Lot Number: P000177741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• 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