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

Model Number	L101
Medical Device Problem Codes	Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that during a routine visit; this pacemaker system was found to be operating in safety mode.Technical services (ts) was contacted for consult review.Ts reviewed provided stored reports and confirmed device to be in safety mode.Ts also noted that a prior consult report from (b)(6) 2024 showed right ventricular automatic threshold (rvat) was detected as greater than programmed amplitude or suspended.Further review showed high pacing thresholds on the right ventricular (rv) lead.Ts advised that changeout urgency should be driven by potential symptoms to current settings and increase in power consumption due to increase in pacing output voltage.Subsequently, additional information was provided that reported that a replacement procedure was performed.The pacemaker was explanted due to safety mode and premature battery depletion (pbd) and replaced with a new device successfully.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that during a routine visit, this pacemaker system was found to be operating in safety mode.Technical services (ts) was contacted for consult review.Ts reviewed provided stored reports and confirmed device to be in safety mode.Ts also noted that a prior consult report from (b)(6) 2024 showed right ventricular automatic threshold (rvat) was detected as greater than programmed amplitude or suspended.Further review showed high pacing thresholds on the right ventricular (rv) lead.Ts advised that changeout urgency should be driven by potential symptoms to current settings and increase in power consumption due to increase in pacing output voltage.Subsequently, additional information was provided that reported that a replacement procedure was performed.The pacemaker was explanted due to safety mode and premature battery depletion (pbd) and replaced with a new device successfully.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Device technical analysis: this product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Device history record review: 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.Labeling review: 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 with labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Risk assessment: 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.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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: 25340677
• Report Number: 2124215-2026-29057
• Device Sequence Number: 10003014
• Product Code: LWP
• UDI-Device Identifier: 00802526558924
• UDI-Public: (01)00802526558924(17)191117
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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: 11/17/2019
• Device Model Number: L101
• Device Catalogue Number: L101
• Device Lot Number: 765419
• 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: 05/05/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 06/25/2026
• Date Device Manufactured: 12/11/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male