MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) ASSURITY MRI; Implantable Pulse Generator, Pacemaker (Non-Crt)

Model Number	PM1272
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	08/21/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that a remote transmission was received indicating a high ventricular rate episode, ventricular tachycardia with no termination and subsequent autopolarity switch on the pacemaker.The pacemaker does not deliver therapy for arrhythmias such as ventricular tachycardia.The clinician subsequently checked on the patient.It was found that the patient was deceased.There was no complaint of malfunction on the pacemaker/system by the physician.

• Brand Name: ASSURITY MRI
• Common Device Name: Implantable Pulse Generator, Pacemaker (Non-Crt)
• 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: 50804903
• Report Number: 2017865-2026-18934
• Device Sequence Number: 13414450
• Product Code: LWP
• UDI-Device Identifier: 05414734509572
• UDI-Public: (01)05414734509572(10)P000227419(17)260831
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P140033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: PM1272
• Device Lot Number: P000227419
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2025
• 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: Death
• Patient Sex: Male