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

Model Number	L101
Medical Device Problem Codes	Use of Device Problem (1670); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Boston scientific issued a field safety notice update to physicians regarding unintended behaviors observed with a software update designed to detect high battery impedance and prevent initiation of safety mode in accolade devices.The associated investigation determined that the software update led to this device experiencing a false positive response that resulted in disablement of the wandless telemetry.Boston scientific has developed a software update to address this unintended behavior.Boston scientific developed and released an additional software update for the accolade family designed to correct the unintended behaviors.This device exhibited the unintended behavior prior to receiving the additional software update.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 difficult to interrogate/telemetry (rf) 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 a review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Based on a thorough review of the reported complaint, the conclusion code cause traced to device design was selected.
Event or Problem Description
It was reported that this pacemaker exhibited an alert message indicating that radio frequency (rf) telemetry was disabled.Analysis of device data was requested.Technical services discussed that this was a false positive explant indicator related to a software update and that all other device functions remain available.This device software was updated, and rf function was restored.This pacemaker remains in service.No adverse patient effects were reported.

• Brand Name: ESSENTIO? 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 25414207
• Report Number: 2124215-2026-30241
• Device Sequence Number: 14906818
• Product Code: LWP
• UDI-Device Identifier: 00802526558924
• UDI-Public: (01)00802526558924(17)240413
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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: 04/13/2024
• Device Model Number: L101
• Device Catalogue Number: L101
• Device Lot Number: 797856
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/05/2026
• Date Device Manufactured: 05/13/2022
• 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: 64 YR
• Patient Sex: Male