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 Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332); No Pacing (3268)
Health Effect - Clinical Codes	Arrhythmia (1721); Dizziness (2194)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented with a near syncopal episode.Interrogation noted a sustained arrythmia, loss of pacing on the pacemaker, as well as failure to interrogate and premature battery depletion.The device4 was explanted and replaced on (b)(6) 2026.No adverse patient consequences were reported.

• 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: 25792071
• Report Number: 2017865-2026-14636
• Device Sequence Number: 14916074
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: (01)05414734510097(10)A000092533(17)210731
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 07/12/2026

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: 07/31/2021
• Device Model Number: PM3562
• Device Lot Number: A000092533
• 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: 06/22/2026
• Initial Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2020
• 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: QUARTETLEADS; TENDRIL STS; TENDRIL STS
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 60 KG