MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO? MRI SR; pacemaker

Model Number	L110
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this pacemaker recorded a code 1003, indicating the voltage is too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis identified potential high impedance within the battery.Technical services (ts) recommended to either schedule a replacement procedure within 28 days or continue monitoring until radio frequency (rf) telemetry is disabled, after which, device replacement is advised.This device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this pacemaker recorded a code 1003, indicating the voltage is too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis identified potential high impedance within the battery.A replacement procedure has been scheduled.As of today, this device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker recorded a code 1003, indicating the voltage is too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis identified potential high impedance within the battery.A replacement procedure has been scheduled.As of today, this device remains in service.No adverse patient effects were reported.Additional information was received indicating this pacemaker was explanted and replaced.No additional patient effects were reported.The device has not been returned.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: ESSENTIO? MRI SR
• Common Device Name: pacemaker
• 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25115679
• Report Number: 2124215-2026-24830
• Device Sequence Number: 18712081
• Product Code: LWP
• UDI-Device Identifier: 00802526558948
• UDI-Public: (01)00802526558948(17)180613
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/04/2026

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: Lay User/Patient
• Device Expiration Date: 06/13/2018
• Device Model Number: L110
• Device Catalogue Number: L110
• Device Lot Number: 718622
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/22/2026
• 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: 04/29/2026
• Supplement Date Received by Manufacturer: 05/07/2026; 05/15/2026; Not provided
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 05/12/2026; 05/22/2026; 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2124215-03/18/26-001-C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male