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

Model Number	L100
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) reverted into safety mode.This device was confirmed to be in safety mode and device replacement was recommended.No adverse patient effects were reported.This crt-p remains in service.
Additional Manufacturer Narrative
Follow up report 1 (device evaluation): the complaint device was not returned to boston scientific; therefore, product analysis could not be performed.Conclusion code was updated to "cause not established" because the reason for the alleged observation(s) could not be determined.Product record reviews did not identify a product quality issue and analysis of available information did not identify a specific complaint cause.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 device displays error message 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.At this point, it can be concluded that unknown factors most probably contributed to the event.
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) reverted into safety mode.This device was confirmed to be in safety mode and device replacement was recommended.No adverse patient effects were reported.This crt-p remains in service.

• Brand Name: ESSENTIO? 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24335040
• Report Number: 2124215-2026-08299
• Device Sequence Number: 18578015
• Product Code: LWP
• UDI-Device Identifier: 00802526558900
• UDI-Public: (01)00802526558900(17)190407
• 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: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: 04/07/2019
• Device Model Number: L100
• Device Catalogue Number: L100
• Device Lot Number: 717355
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/28/2026
• Date Device Manufactured: 06/21/2017
• 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 Sex: Female