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

Model Number	L111
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker recorded a code 1003, indicating the voltage was too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis identified potential high impedance within the battery.Device replacement was recommended.The device remains in service.No adverse patient effects were reported.Additional information was provided that the patient was contacted regarding a recommended generator replacement based on technical services guidance, and advisory information was provided.The device replacement procedure has been scheduled.No adverse patient effects have been reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this pacemaker recorded a code 1003, indicating the voltage was too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis identified potential high impedance within the battery.Device replacement was recommended.The device remains in service.No adverse patient effects were reported.Additional information was provided that the patient was contacted regarding a recommended generator replacement based on technical services guidance, and advisory information was provided.The device replacement procedure has been scheduled.No adverse patient effects have been reported.Additional information was received indicating that the device was explanted.The product has not been returned for analysis.No additional adverse patient effects have been reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• 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: 50659594
• Report Number: 2124215-2026-47728
• Device Sequence Number: 9512689
• Product Code: LWP
• UDI-Device Identifier: 00802526558962
• UDI-Public: (01)00802526558962(17)190830
• 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: 2018
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: 08/30/2019
• Device Model Number: L111
• Device Catalogue Number: L111
• Device Lot Number: 314197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/08/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 09/12/2017
• 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: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female