MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Quadra Allure MP RF CRT-P; Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

Model Number	PM3262
Medical Device Problem Code	Under-Sensing (1661)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient¿s pacemaker exhibited undersensing of the atrial channel in 2023.Programming changes were performed to vvir mode on 1 may 2023.Subsequently, the pacemaker was explanted on 14 april 2026 because it had reached the elective replacement indicator (eri).The patient¿s condition was not known.
Additional Manufacturer Narrative
Further information was requested but not received.

• Brand Name: Quadra Allure MP RF CRT-P
• Common Device Name: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
• 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: 50268646
• Report Number: 2017865-2026-17159
• Device Sequence Number: 10316866
• Product Code: NIK
• UDI-Device Identifier: 05414734509091
• UDI-Public: (01)05414734509091(10)A000057675(17)191130
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 2026
• 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): 08/17/2026

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 Expiration Date: 11/30/2019
• Device Model Number: PM3262
• Device Lot Number: A000057675
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• 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: 07/28/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Quartet Lead; Tendril Lead; US Tendril SDX Lead
• Patient Age: 81 YR
• Patient Sex: Male