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

Model Number	L110
Medical Device Problem Codes	Pacing Problem (1439); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported the pacemaker patient passed away on (b)(6) 2026.The patient's daughter stated that the pacemaker "failed to work".Technical services discussed that if the patient had damage to the myocardium the ability to pace may have been compromised.In addition, if the patient had a fast arrhythmic event the pacemaker doesn't treat that.The patient was cremated, and it is unknown if the pacemaker will be returned.The daughter stated that she would reach out to the doctor's office.It was additionally reported that the patient had been on dialysis at the time of death.The pacemaker had been set with a lower rate limit of 40 beats/minute; however, monitors had been displaying 30 beats/minute which was possibly misinterpreted.Despite good faith effort, no further details were obtained regarding the event.
Event or Problem Description
It was reported the pacemaker patient passed away on (b)(6) 2026.The patient's daughter stated that the pacemaker "failed to work".Technical services discussed that if the patient had damage to the myocardium the ability to pace may have been compromised.In addition, if the patient had a fast arrhythmic event the pacemaker doesn't treat that.The patient was cremated, and it is unknown if the pacemaker will be returned.The daughter stated that she would reach out to the doctor's office.It was additionally reported that that the patient had been on dialysis at the time of death.The pacemaker had been set with a lower rate limit of 40 beats/minute; however, monitors had been displaying 30 beats/minute which was possibly misinterpreted.Despite good faith effort, no further details were obtained regarding the event.
Additional Manufacturer Narrative
Device technical analysis: this product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Device history record review: a review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Labeling review: review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Risk assessment: a risk review was completed and confirmed that the event of death was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• Brand Name: ESSENTIO? MRI SR
• 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 ; +1(651)582-6168
• MDR Report Key: 25349933
• Report Number: 2124215-2026-29126
• Device Sequence Number: 10311480
• Product Code: LWP
• UDI-Device Identifier: 00802526558948
• UDI-Public: (01)00802526558948(17)260312
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2026

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: 03/12/2026
• Device Model Number: L110
• Device Catalogue Number: L110
• Device Lot Number: 914985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 08/21/2026
• Date Device Manufactured: 03/22/2024
• 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: Death
• Patient Age: 85 YR
• Patient Sex: Male