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

Model Number	PM3242
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference numbers: 2017865-2024-71105, 2017865-2024-71106, and 2017865-2024-71107.It was reported that the patient presented remotely to the clinic via merlin.Net transmission.Transmissions revealed that the pacemaker, right atrial lead and left ventricular lead exhibited electromagnetic interference (emi).The right ventricular lead exhibited noise oversensing resulting pacing inhibition.No intervention and patient consequences was reported.
Additional Manufacturer Narrative
Correction section h6: medical device problem code was updated to over-sensing since it was not known whether the noise that led to pacing inhibition was lead-related or device-related.
Event or Problem Description
New information received notes that the patient's pacemaker was explanted.No patient consequences were reported.
Additional Manufacturer Narrative
Reported events of sensing noise was not confirmed.The device was at eol level upon receipt.Analysis performed, including cross talk test, did not show any anomalies.Longevity assessment was performed, and device has exceeded the total projected longevity and is considered normal battery depletion.

• 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 20793601
• Report Number: 2017865-2024-71104
• Device Sequence Number: 7980460
• Product Code: NIK
• UDI-Device Identifier: 05414734507912
• UDI-Public: (01)05414734507912(10)A000064823(17)200229
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/16/2025

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: A000064823
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: 12/16/2024; 10/29/2025; 12/09/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/18/2024; 11/20/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female