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

Model Number	L111
Medical Device Problem Codes	Premature Discharge of Battery (1057); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker was explanted due to an product performance issue.This pacemaker was successfully explanted and replaced with another device.No additional adverse patient effects were reported outside the revision procedure.At this time, this product has not been returned for analysis.\ \ additional information was received that this pacemaker was successfully explanted and replaced due to a code 1003, indicative that the voltage was too low for projected remaining capacity upon interrogation.No adverse patient effects were reported.This product is expected to return.
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.
Event or Problem Description
It was reported that this pacemaker was explanted due to an product performance issue.This pacemaker was successfully explanted and replaced with another device.No additional adverse patient effects were reported outside the revision procedure.At this time, this product has not been returned for analysis.

• Brand Name: ESSENTIO? MRI 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: 50699820
• Report Number: 2124215-2026-48302
• Device Sequence Number: 18545306
• Product Code: LWP
• UDI-Device Identifier: 00802526558962
• UDI-Public: (01)00802526558962(17)181110
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: 11/10/2018
• Device Model Number: L111
• Device Catalogue Number: L111
• Device Lot Number: 262734
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/09/2026
• Supplement Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 11/25/2016
• 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: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female