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

Model Number	PM3242
Medical Device Problem Code	Unexpected Mode Switch (4076)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
It was reported that the pacemaker exhibited a backup vvi mode.The patient had been experiencing discomfort.The pacemaker was explanted and replaced.The patient was stable.

• Brand Name: ALLURE QUADRA RF 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 21134888
• Report Number: 2017865-2025-10725
• Device Sequence Number: 7677283
• Product Code: NIK
• UDI-Device Identifier: 05414734507912
• UDI-Public: (01)05414734507912(10)A000063335(17)200229
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: 02/29/2020
• Device Model Number: PM3242
• Device Lot Number: A000063335
• Was Device Available for Evaluation?: No
• 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: 12/24/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2018
• 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: LEFT VENTRICULAR LEAD; RIGHT ATRIAL LEAD; RIGHT VENTRICULAR LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 80 KG