MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Assurity RF DR; Pulse Generator, Permanent, Implantable

Model Number	PM2240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's pacemaker, right atrial (ra) lead and right ventricular (rv) lead were explanted on (b)(6) 2026 due to infection.Temporary pacemaker was placed until the infection was resolved; the patient was subsequently implanted with a new pacemaker system on (b)(6) 2026.The patient was in stable condition.
Additional Manufacturer Narrative
A device history record (dhr) review was performed and review of the sterilization records confirmed normal sterilization cycles for the products.The device met specifications prior to leaving abbott manufacturing facilities.The cause of infection could not be determined.Further information was requested but not received.

• Brand Name: Assurity RF DR
• Common Device Name: Pulse Generator, Permanent, Implantable
• 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: 50910666
• Report Number: 2017865-2026-20455
• Device Sequence Number: 5804594
• Product Code: NVZ
• UDI-Device Identifier: 05414734507073
• UDI-Public: (01)05414734507073(10)A000013270(17)170430
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 09/28/2026

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: 04/30/2017
• Device Model Number: PM2240
• Device Lot Number: A000013270
• 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: 09/15/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2015
• 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: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male