MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO? MRI SR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	L110
Medical Device Problem Codes	Use of Device Problem (1670); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional pertinent information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this pacemaker exhibited an alert message indicating that remote monitoring was disabled.Technical services (ts) was consulted and determined that this was likley a false positive indicator related to a software update.Ts indicated that full telemetry function could be restored via a software update.This pacemaker remains in service.No adverse patient effects were reported.

• Brand Name: ESSENTIO? MRI SR
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24916461
• Report Number: 2124215-2026-21047
• Device Sequence Number: 13060439
• Product Code: LWP
• UDI-Device Identifier: 00802526558948
• UDI-Public: (01)00802526558948(17)220930
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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: Lay User/Patient
• Device Expiration Date: 09/30/2022
• Device Model Number: L110
• Device Catalogue Number: L110
• Device Lot Number: 822526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 06/09/2026
• Date Device Manufactured: 10/13/2020
• 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
• Patient Age: 87 YR
• Patient Sex: Female