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

Model Number	L100
Medical Device Problem Codes	Premature Discharge of Battery (1057); Use of Device Problem (1670); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker exhibited difficulties to interrogate.Technical services (ts) performed further analysis and determined that the device had recorded a true positive remote monitoring disabled (rmd) alert for radio frequency (rf) telemetry due to a low loaded battery voltage measurement.Device replacement was recommended, and the findings were communicated to the health care professional (hcp).No adverse patient effects were reported.This pacemaker remains in service.
Event or Problem Description
It was reported that this pacemaker exhibited difficulties to interrogate.Technical services (ts) performed further analysis and determined that the device had recorded a true positive remote monitoring disabled (rmd) alert for radio frequency (rf) telemetry due to a low loaded battery voltage measurement.Device replacement was recommended, and the findings were communicated to the health care professional (hcp).No adverse patient effects were reported.This pacemaker remains in service.Additional information was received that this pacemaker recorded a code 1003, indicative of voltage was too low for projected remaining capacity alert.No adverse patient effects were reported.This pacemaker remains in service.Additional information was received that this pacemaker was successfully explanted and replaced.No additional adverse patient effects were reported outside the revision procedure.At this time, this product has not been returned for analysis.
Event or Problem Description
It was reported that this pacemaker exhibited difficulties to interrogate.Technical services (ts) performed further analysis and determined that the device had recorded a true positive remote monitoring disabled (rmd) alert for radio frequency (rf) telemetry due to a low loaded battery voltage measurement.Device replacement was recommended, and the findings were communicated to the health care professional (hcp).No adverse patient effects were reported.This pacemaker remains in service.Additional information was received that this pacemaker recorded a code 1003, indicative of voltage was too low for projected remaining capacity alert.No adverse patient effects were reported.This pacemaker remains in service.Additional information was received that this pacemaker was successfully explanted and replaced.No additional adverse patient effects were reported outside the revision procedure.At this time, this product has not been returned for analysis.
Additional Manufacturer Narrative
Corrected fields: d2a: common device name.E1: initial reporter first name initial reporter last name and rfb init reporter first name and last name initial reporter email.E2: health professional? e3: occupation.The device was not returned for analysis; therefore, a technical analysis could not be performed.Analysis of the device memory confirmed that a code 1003 alert was recorded and that zip telemetry was disabled.Boston scientific previously issued a field safety notice to notify physicians of the potential for accolade family pacemaker and cardiac resynchronization therapy pacemaker (crt-p) devices to initiate safety mode when high battery impedance is detected.Engineers determined that the code 1003 alert and the disablement of zip telemetry was due to a subsequently released software update that was designed to detect the onset of high battery impedance and prevent the initiation of safety mode in an ambulatory setting.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.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.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause traced to device design.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.Analysis of the device memory confirmed that a code 1003 alert was recorded and/or that zip telemetry was disabled.Boston scientific previously issued a field safety notice to notify physicians of the potential for accolade family pacemaker and cardiac resynchronization therapy pacemaker (crt-p) devices to initiate safety mode when high battery impedance is detected.Engineers determined that the code 1003 alert and/or that zip telemetry was disabled was due to a subsequently released software update that was designed to detect the onset of high battery impedance and prevent the initiation of safety mode in an ambulatory setting.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.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.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause traced to device design.

• Brand Name: ESSENTIO? 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 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: 25340674
• Report Number: 2124215-2026-29047
• Device Sequence Number: 10003011
• Product Code: LWP
• UDI-Device Identifier: 00802526558900
• UDI-Public: (01)00802526558900(17)180426
• 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: 2017
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/15/2026

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: 04/26/2018
• Device Model Number: L100
• Device Catalogue Number: L100
• Device Lot Number: 712194
• 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: 05/26/2026
• Supplement Date Received by Manufacturer: Not provided; 09/02/2026; 09/07/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 08/20/2026; 09/09/2026; 09/15/2026
• Date Device Manufactured: 05/19/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2124215-03/18/26-001-C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male