MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO? DR; PACEMAKERS

Model Number	L101
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the remote monitor was disabled (rmd) and latitude was no longer able to monitor this patient's pacemaker device due to limited battery capacity.Upon review, technical services (ts) stated that remote monitoring disabled on (b)(6) 2026 due to limited battery capacity and the explant indicator reached on (b)(6) 2000.Ts stated that it was likely that this was a false rmd trigger due to magnet application during the loaded battery measurement as this battery has not yet reached 50% of the eri capacity.Ts recommended smr6 which will restore full telemetry function to such units.This device remains in service.No adverse patient effects were reported.

• Brand Name: ESSENTIO? DR
• Common Device Name: PACEMAKERS
• 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: 25717612
• Report Number: 2124215-2026-35929
• Device Sequence Number: 10598345
• Product Code: LWP
• UDI-Device Identifier: 00802526558924
• UDI-Public: (01)00802526558924(17)251121
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/06/2026

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: 11/21/2025
• Device Model Number: L101
• Device Catalogue Number: L101
• Device Lot Number: 806246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 07/06/2026
• Date Device Manufactured: 12/04/2023
• 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: 88 YR
• Patient Sex: Male