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

Model Number	L101
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker was exhibiting intermittent loss of capture (loc) and noise were observed on the right ventricular (rv) lead, with no asystole greater than two seconds reported.A right ventricular lead revision had been planned; however, during preparation for the procedure, additional noise was noted on the right atrial (ra) lead, resulting in cancellation of the procedure per physician discretion.It was further reported that the patient will be referred for extraction of both leads and implantation of a new system.Technical services (ts) reviewed the available data and indicated that noise was not oversensed on the presenting rv electrogram; however, findings were consistent with rv loss of capture, with evidence suggestive of intrinsic ventricular escape rhythm.Ts also noted that no ra lead noise was observed on the presenting electrogram.As of this time, this pacemaker remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product remains implanted and in-service; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.

• 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: 25488753
• Report Number: 2124215-2026-31607
• Device Sequence Number: 9735564
• Product Code: LWP
• UDI-Device Identifier: 00802526558924
• UDI-Public: (01)00802526558924(17)210212
• 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: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2026

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: 02/12/2021
• Device Model Number: L101
• Device Catalogue Number: L101
• Device Lot Number: 779816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Supplement Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 07/06/2026
• Date Device Manufactured: 03/04/2019
• 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 Sex: Female