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

Model Number	L100
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
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 during a retrospective review of device data it was identified that this implantable pacemaker recorded a code 1003, which states that the voltage is too low for projected remaining capacity.The device has been explanted at this time and has not yet been returned for analysis.No other information was provided.No additional adverse patient effects were reported.

• Brand Name: ESSENTIO? SR
• Common Device Name: Implantable 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: 24634959
• Report Number: 2124215-2026-15051
• Device Sequence Number: 8698261
• Product Code: LWP
• UDI-Device Identifier: 00802526558900
• UDI-Public: (01)00802526558900(17)180217
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

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: 02/17/2018
• Device Model Number: L100
• Device Catalogue Number: L100
• Device Lot Number: 709338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 03/03/2016
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male