MAUDE Adverse Event Report: ABBOTT QUADRA ALLURE MP; Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Model Number	PM3542
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that far field r-wave oversensing and inappropriate mode switching was observed on the device.Abbott technical support recommended reprogramming to resolve the event, however, no intervention has been performed at this time to resolve the event.The patient was in stable condition and will continue to be monitored.

• Brand Name: QUADRA ALLURE MP
• Common Device Name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 22891079
• Report Number: 2017865-2025-98555
• Device Sequence Number: 8851828
• Product Code: NKE
• UDI-Device Identifier: 05414734510080
• UDI-Public: (01)05414734510080(10)P000196088(17)250930
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/25/2025

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: 09/30/2025
• Device Model Number: PM3542
• Device Lot Number: P000196088
• 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: 08/12/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2024
• 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