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

Model Number	L100
Medical Device Problem Code	Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker was unable to be interrogated with wand.The device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker was unable to be interrogated with wand.The device remains in service.No adverse patient effects were reported.Additional information obtained, the device was explanted and replaced due to normal battery depletion (nbd).The device was not able to be interrogated due to being in end of life (eol).

• 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23910911
• Report Number: 2124215-2025-93490
• Device Sequence Number: 10024280
• Product Code: LWP
• UDI-Device Identifier: 00802526558900
• UDI-Public: (01)00802526558900(17)180217
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: 02/17/2018
• Device Model Number: L100
• Device Catalogue Number: L100
• Device Lot Number: 709320
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 12/30/2025
• Date Device Manufactured: 03/02/2016
• 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
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male