MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO? SR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	L100
Medical Device Problem Codes	Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Fall (1848); Syncope/Fainting (4411); Vertebral Fracture (4520)
Date of Event	06/17/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that this pacemaker entered safety mode, resulting in pacing inhibition and multiple syncopal episodes.The patient fell and sustained a spinal fracture, and chest compressions were administered due to pauses seen on telemetry.This device was explanted and replaced.This device was returned and is pending analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Analysis of the device confirmed that it was operating in safety mode and that critical therapy remained available.Engineers determined that this device was demonstrating behavior consistent with a high battery impedance, which put this device at risk of experiencing transient voltage decreases (and associated resets) during telemetry or other normal, higher-power operations.When battery voltage drops below a minimum threshold, a system reset is performed.If three system resets occur within a 48-hour period, the device is designed to enter safety mode operation to maintain back-up pacing with pre-defined settings.Boston scientific has issued a field safety notice to notify physicians of the potential for accolade family pacemaker and cardiac resynchronization therapy pacemaker (crt-p) devices to exhibit this behavior.
Event or Problem Description
It was reported that this pacemaker entered safety mode, resulting in pacing inhibition and multiple syncopal episodes.The patient fell and sustained a spinal fracture, and chest compressions were administered due to pauses seen on telemetry.This device was explanted and replaced.This device returned for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Analysis of the device confirmed that it was operating in safety mode and that critical therapy remained available.Engineers determined that this device was demonstrating behavior consistent with a high battery impedance, which put this device at risk of experiencing transient voltage decreases (and associated resets) during telemetry or other normal, higher-power operations.When battery voltage drops below a minimum threshold, a system reset is performed.If three system resets occur within a 48-hour period, the device is designed to enter safety mode operation to maintain back-up pacing with pre-defined settings.Boston scientific has issued a field safety notice to notify physicians of the potential for accolade family pacemaker and cardiac resynchronization therapy pacemaker (crt-p) devices to exhibit this behavior.
Event or Problem Description
It was reported that this pacemaker entered safety mode, resulting in pacing inhibition and multiple syncopal episodes.The patient fell and sustained a spinal fracture, and chest compressions were administered due to pauses seen on telemetry.This device was explanted and replaced.This device returned for analysis.No additional adverse patient effects were reported.Additional information was provided to the local boston scientific sales representative from the patient's physician, indicating the patient passed away almost three months later due to the injuries and complications that occurred when the device reverted to safety mode.
Event or Problem Description
It was reported that this pacemaker entered safety mode, resulting in pacing inhibition and multiple syncopal episodes.The patient fell and sustained a spinal fracture, and chest compressions were administered due to pauses seen on telemetry.This device was explanted and replaced.This device returned for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Analysis of the device confirmed that it was operating in safety mode and that critical therapy remained available.Engineers determined that this device was demonstrating behavior consistent with a high battery impedance, which put this device at risk of experiencing transient voltage decreases (and associated resets) during telemetry or other normal, higher-power operations.When battery voltage drops below a minimum threshold, a system reset is performed.If three system resets occur within a 48-hour period, the device is designed to enter safety mode operation to maintain back-up pacing with pre-defined settings.Boston scientific has issued a field safety notice to notify physicians of the potential for accolade family pacemaker and cardiac resynchronization therapy pacemaker (crt-p) devices to exhibit this behavior.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Analysis of the device confirmed that it was operating in safety mode and that critical therapy remained available.Engineers determined that this device was demonstrating behavior consistent with a high battery impedance, which put this device at risk of experiencing transient voltage decreases (and associated resets) during telemetry or other normal, higher-power operations.When battery voltage drops below a minimum threshold, a system reset is performed.If three system resets occur within a 48-hour period, the device is designed to enter safety mode operation to maintain back-up pacing with pre-defined settings.Boston scientific has issued a field safety notice to notify physicians of the potential for accolade family pacemaker and cardiac resynchronization therapy pacemaker (crt-p) devices to exhibit this behavior.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of manufacturing deficiency.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.A risk review was completed and confirmed that the event of device displays error message 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.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.
Event or Problem Description
It was reported that this pacemaker entered safety mode, resulting in pacing inhibition and multiple syncopal episodes.The patient fell and sustained a spinal fracture, and chest compressions were administered due to pauses seen on telemetry.This device was explanted and replaced.This device returned for analysis.No additional adverse patient effects were reported.Additional information was provided to the local boston scientific sales representative from the patient's physician, indicating the patient passed away almost three months later due to the injuries and complications that occurred when the device reverted to safety mode.

• Brand Name: ESSENTIO? SR
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 22414182
• Report Number: 2124215-2025-44928
• Device Sequence Number: 20920973
• Product Code: LWP
• UDI-Device Identifier: 00802526558900
• UDI-Public: (01)00802526558900(17)170205
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/06/2026

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: 02/05/2017
• Device Model Number: L100
• Device Catalogue Number: L100
• Device Lot Number: 465832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 09/25/2025; 11/03/2025; 12/31/2025; 05/04/2026
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 10/19/2025; 12/02/2025; 01/23/2026; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2015
• 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; Death
• Patient Age: 87 YR
• Patient Sex: Male