MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO? MRI EL DR; Pacemaker

Model Number	L131
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker exhibited a code 1003 voltage alert, indicative that the voltage was too low for the projected remaining battery capacity.Technical services (ts) reviewed the available device data and noted that the device had recently been updated to newest software update.The voltage alert was determined to have likely triggered shortly after the software update due to activation of the monitoring algorithm.Engineering analysis confirmed that remote monitoring functionality remained available and that approximately six months of rf telemetry availability remained.Continued monitoring was recommended, until radio frequency (rf) telemetry is disabled, at which time replacement should be performed.No adverse patient effects were reported.This pacemaker remains in service.

• Brand Name: ESSENTIO? MRI EL 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 E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50806043
• Report Number: 2124215-2026-49735
• Device Sequence Number: 15614256
• Product Code: LWP
• UDI-Device Identifier: 00802526559006
• UDI-Public: (01)00802526559006(17)200711
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 07/11/2020
• Device Model Number: L131
• Device Catalogue Number: L131
• Device Lot Number: 801333
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 08/01/2018
• 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: 56 YR
• Patient Sex: Male