MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO SR; IMPLANTABLE PACEMAKER

Model Number	L100
Medical Device Problem Codes	Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Interrogation Problem (4017)
Health Effect - Clinical Codes	Bradycardia (1751); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable pacemaker could not be interrogated due to possible low battery as the device was implanted for about 10 years.The patient showed up in the emergency room with a heart rate of 27 beats per minute.The field representative was still not able to interrogate the device and got a red screen for voltage too low for projected remaining capacity in storage mode.Subsequently, the device was explanted and replaced with a new device.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This supplemental correction report was filed to capture correction on h6: device codes.
Event or Problem Description
It was reported that this implantable pacemaker could not be interrogated due to possible low battery as the device was implanted for about 10 years.The patient showed up in the emergency room with a heart rate of 27 beats per minute.The field representative was still not able to interrogate the device and got a red screen for voltage too low for projected remaining capacity in storage mode.Subsequently, the device was explanted and replaced with a new device.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This supplemental correction report was filed to capture correction on h6: device codes.Revision to fields f10 and h6 patient codes.This supplemental report has been created to capture additional information and information correction.
Event or Problem Description
It was reported that this implantable pacemaker could not be interrogated due to possible low battery as the device was implanted for about 10 years.The patient showed up in the emergency room with a heart rate of 27 beats per minute.The field representative was still not able to interrogate the device and got a red screen for voltage too low for projected remaining capacity in storage mode.Subsequently, the device was explanted and replaced with a new device.No additional adverse patient effects were reported.

• Brand Name: ESSENTIO SR
• Common Device Name: IMPLANTABLE 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 ; 6515826168
• MDR Report Key: 22135390
• Report Number: 2124215-2025-36360
• Device Sequence Number: 8437224
• Product Code: LWP
• UDI-Device Identifier: 00802526558900
• UDI-Public: (01)00802526558900(17)160908
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2026

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: 09/08/2016
• Device Model Number: L100
• Device Catalogue Number: L100
• Device Lot Number: 464348
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 06/12/2025; 01/06/2026
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/12/2025; 01/22/2026
• Date Device Manufactured: 10/03/2014
• 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: Hospitalization; Required Intervention
• Patient Sex: Female