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	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this pacemaker recorded a code 1003, which states that the voltage is too low for projected remaining capacity.Data analysis identified potential high impedance within the battery.Device replacement was recommended.No adverse patient effects were reported, and the device remains in service.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Data analysis of the device confirmed that a low voltage alert, code 1003, was recorded and that critical therapy remained available.Engineers determined that this device was demonstrating behavior consistent with a high battery impedance, which puts this device at risk of experiencing transient voltage decreases (and associated resets) during telemetry or other normal, higher-power operations.When the device detects an elevated battery impedance, a code 1003 is displayed to alert users that a high battery impedance condition exists.If the device remains in service, rf telemetry will be disabled before the battery impedance reaches a level where safety mode can occur.Boston scientific has issued a field safety notice to notify physicians of the potential for accolade family pacemaker and cardiac resynchronization therapy pacemaker (crt-p) devices to exhibit this behavior.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of message - error code 1003 was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of manufacturing deficiency.
Event or Problem Description
It was reported that this pacemaker recorded a code 1003, which states that the voltage is too low for projected remaining capacity.Data analysis identified potential high impedance within the battery.Device replacement was recommended.No adverse patient effects were reported, and the device remains in service.

• 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 24020376
• Report Number: 2124215-2026-01516
• Device Sequence Number: 8939542
• Product Code: LWP
• UDI-Device Identifier: 00802526558900
• UDI-Public: (01)00802526558900(17)191122
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall,Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2026

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: 11/22/2019
• Device Model Number: L100
• Device Catalogue Number: L100
• Device Lot Number: 720313
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 04/07/2026; 08/03/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 04/08/2026; 08/07/2026
• Date Device Manufactured: 12/01/2017
• 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: 64 YR
• Patient Sex: Male