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

Model Number	L131
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the health care professional (hcp) called technical services (ts) for further review of this pacemaker stored atrial tachy response (atr) and signal artifact monitor (sam) events.Upon review, the atr episodes showed oversensing noise on both right atrial (ra) and right ventricular (rv) leads.The oversensed noise appears to be electromagnetic interference (emi) in nature.Further review of the sam events shows the emi noise led to minute ventilation (mv) to be disabled by the sam feature.The hcp noted patient was in a procedure at the time the events were recorded.It is believed that the emi oversensing from the electrocautery led to the inappropriate atr and sam events.Ts discussed programming optimization recommendations.No adverse patient effects were reported.This pacemaker remains in service.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• 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: 50601334
• Report Number: 2124215-2026-46252
• Device Sequence Number: 10710115
• Product Code: LWP
• UDI-Device Identifier: 00802526559006
• UDI-Public: (01)00802526559006(17)190407
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 04/07/2019
• Device Model Number: L131
• Device Catalogue Number: L131
• Device Lot Number: 751370
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 05/08/2017
• 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
• Patient Age: 73 YR
• Patient Sex: Female