MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Quadra Allure MP CRT-P; Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

Model Number	PM3562
Medical Device Problem Code	Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pacemaker was found in back-up mode prior to the implant procedure.The device was not implanted.There was no patient involved.
Additional Manufacturer Narrative
The reported event of device in unexpected mode switch was confirmed.The device was received in backup mode with normal telemetry communication.Analysis of the device image indicated the device went to bvvi due to hardware reset error.The device was restored by reloading product code followed by analysis indicating normal interrogation results.Backup vvi mode was reproduced at lower temperature, and this is consistent with an integrated circuit anomaly.Assessment of total projected longevity was performed, and the device was found to have appropriate remaining longevity.A device history record (dhr) review was performed and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: Quadra Allure MP CRT-P
• Common Device Name: Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
• Manufacturer (Section D): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50515946
• Report Number: 2017865-2026-18247
• Device Sequence Number: 16122607
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: (01)05414734510097(10)A000184222(17)270731
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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 Model Number: PM3562
• Device Lot Number: A000184222
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/13/2026
• 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: 08/10/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2026
• 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