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

Model Number	L101
Medical Device Problem Codes	Use of Device Problem (1670); Data Problem (3196); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker exhibited an alert indicating that remote monitoring (rmd) was no longer available due to limited battery capacity, with an explant indicator displaying a date of (b)(6) 2000.Technical services (ts) reviewed the information and determined this is likely a false positive trigger, potentially related to magnet application during a battery measurement, as the device has not reached the expected elective replacement indicator (eri) threshold.Ts noted that this behavior may be resolved with the applicable software update, which restores full telemetry functionality and the plan is to further evaluate on the next in-clinic visit.No adverse patient effects were reported.This pacemaker remains in service.Additional information was received that this device was successfully explanted and replaced.No additional adverse patient effects were reported outside the revision procedure.At this time, this product has been returned and the analysis is being performed.
Additional Manufacturer Narrative
Follow up report 1 (additional information): this report is being submitted to update field b5: describe event or problem, section b and field h6: device codes, section h.

• Brand Name: ESSENTIO? DR
• 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: 25586437
• Report Number: 2124215-2026-33152
• Device Sequence Number: 5752083
• Product Code: LWP
• UDI-Device Identifier: 00802526558924
• UDI-Public: (01)00802526558924(17)190926
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 06/22/2026

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: 09/26/2019
• Device Model Number: L101
• Device Catalogue Number: L101
• Device Lot Number: 764046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/22/2026
• Date Device Manufactured: 10/25/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male